(Non-active Class I Medical Devices)

Ophthalmic devices are designed to prevent and potential eye damage, disease or any injuries. Ophthalmic devices covers the various design types and applications such as glasses, intraocular lenses, diagnostics, contact lenses, implants, lasers, solutions and surgical instruments. As per FDA Ophthalmic devices are classified under part 886 as Diagnostic devices, Prosthetic devices, Surgical devices and Therapeutic devices.

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Product code
HJC	Device Name	Esthesiometer, Ocular
	Class	1
	Regulation Name	Ocular esthesiometer
	Regulation No.	886.1040
	Identification	An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOX	Device Name	Chart, Visual Acuity
	Class	1
	Regulation Name	Visual acuity chart.
	Regulation No.	886.1150
	Identification	A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HIT	Device Name	Tester, Color Vision
	Class	1
	Regulation Name	Color vision tester
	Regulation No.	886.1170.
	Identification	A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HMT	Device Name	Distometer
	Class	1
	Regulation Name	Distometer
	Regulation No.	886.1190
	Identification	A distometer is a device intended to measure the distance between the cornea and a corrective lens during refraction to help measure the change of the visual image when a lens is in place.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOW	Device Name	Drum, Opticokinetic
	Class	1
	Regulation Name	Optokinetic drum
	Regulation No.	886.1200
	Identification	An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HLS	Device Name	Exophthalmometer.
	Class	1
	Regulation Name	Exophthalmometer.
	Regulation No.	886.1270
	Identification	An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKG	Device Name	Fornixscope
	Class	1
	Regulation Name	Fornixscope
	Regulation No.	886.1320.
	Identification	A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOQ	Device Name	Grid, Amsler
	Class	1
	Regulation Name	Amsler grid
	Regulation No.	886.1330.
	Identification	An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

HPD	Device Name	Lens, Bagolini
	Class	1
	Regulation Name	Bagolini lens
	Regulation No.	886.1375
	Identification	A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not obscure visualization of objects. The device is placed in a trial frame and intended to determine harmonious/anomalous retinal correspondence (a condition in which corresponding points on the retina have the same directional values).
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HJL	Device Name	Lens, Condensing, Diagnostic
	Class	1
	Regulation Name	Diagnostic condensing lens
	Regulation No.	886.1380
	Identification	A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HJI	Device Name	Lens, Fundus, Hruby, Diagnostic
	Class	1
	Regulation Name	Diagnostic Hruby fundus lens.
	Regulation No.	886.1395
	Identification	A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKR	Device Name	Lens, Maddox
	Class	1
	Regulation Name	Maddox lens.
	Regulation No.	886.1400
	Identification	A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device is intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HPC	Device Name	Set, Lens, Trial, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic trial lens set
	Regulation No.	886.1405
	Identification	An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HPB	Device Name	Clip, Lens, Trial, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic trial lens clip
	Regulation No.	886.1410
	Identification	An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HPA	Device Name	Frame, Trial, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic trial lens frame.
	Regulation No.	886.1415
	Identification	An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HLN	Device Name	Gauge, Lens, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic lens gauge.
	Regulation No.	886.1420
	Identification	An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HLC	Device Name	Instrument, Measuring, Stereopsis
	Class	1
	Regulation Name	Stereopsis measuring instrument
	Regulation No.	886.1460
	Identification	A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKF	Device Name	Instrument, Measuring, Stereopsis
	Class	1
	Regulation Name	Headband mirror
	Regulation No.	886.1500.
	Identification	A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKW	Device Name	Prism, Bar, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic bar prism
	Regulation No.	886.1650
	Identification	An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient’s eyes.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKT	Device Name	Prism, Fresnel, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic Fresnel prism
	Regulation No.	886.1655
	Identification	An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKS	Device Name	Prism, Gonioscopic
	Class	1
	Regulation Name	Gonioscopic prism.
	Regulation No.	886.1660
	Identification	A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKQ	Device Name	Prism, Rotary, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic rotary prism
	Regulation No.	886.1665
	Identification	An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation).
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HMH	Device Name	Prism, Rotary, Ophthalmic
	Class	1
	Regulation Name	Skiascopic rack
	Regulation No.	886.1750
	Identification	A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended as an aid in refraction.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKN	Device Name	Prism, Rotary, Ophthalmic
	Class	1
	Regulation Name	Manual refractor
	Regulation No.	886.1770.
	Identification	A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKN	Device Name	Refractor, Manual, Non-Powered, Including Phoropter
	Class	1
	Regulation Name	Manual refractor
	Regulation No.	886.1770.
	Identification	A manual refractor is a device that is a set of lenses of various dioptric powers intended to measure the refractive error of the eye.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HLE	Device Name	Ruler, Nearpoint (Punctometer)
	Class	1
	Regulation Name	Nearpoint ruler.
	Regulation No.	886.1790
	Identification	A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to which the visual lines are directed when convergence is at its maximum).
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

KYD	Device Name	Strip, Schirmer
	Class	1
	Regulation Name	Schirmer strip.
	Regulation No.	886.1800
	Identification	A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient’s lower eyelid to stimulate and evaluate formation of tears.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOR	Device Name	Simulatan (Including Crossed Cylinder)
	Class	1
	Regulation Name	Simulatan (including crossed cylinder).
	Regulation No.	886.1840
	Identification	A simulatan (including crossed cylinder) is a device that is a set of pairs of cylinder lenses that provides various equal plus and minus refractive strengths. The lenses are arranged so that the user can exchange the positions of plus and minus cylinder lenses of equal strengths. The device is intended for subjective refraction (refraction in which the patient judges whether a given object is clearly in focus, as the examiner uses different lenses).
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HLP	Device Name	Target, Fusion And Stereoscopic
	Class	1
	Regulation Name	Fusion and stereoscopic target
	Regulation No.	886.1880
	Identification	A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (886.1870).
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

HKD	Device Name	Tape, Nystagmus
	Class	1
	Regulation Name	Nystagmus tape.
	Regulation No.	886.1905
	Identification	Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient’s field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

NCK	Device Name	Button, Iris, Eye, Artificial
	Class	1
	Regulation Name	Artificial eye
	Regulation No.	886.3200
	Identification	An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient’s eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HQH	Device Name	Eye, Artificial, Non-Custom
	Class	1
	Regulation Name	Artificial eye
	Regulation No.	886.3200
	Identification	An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient’s eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HQJ	Device Name	Implant, Absorbable, (Scleral Buckling Methods)
	Class	1
	Regulation Name	Absorbable implant (scleral buckling method)
	Regulation No.	886.3300
	Identification	An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HMS	Device Name	Drum, Eye Knife Test
	Class	1
	Regulation Name	Ophthalmic knife test drum
	Regulation No.	886.4230.
	Identification	An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

MSS	Device Name	Folders And Injectors, Intraocular Lens (Iol)
	Class	1
	Regulation Name	Intraocular lens guide
	Regulation No.	886.4300
	Identification	An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
	Status	510(k)
	Remarks	NIL

OTZ	Device Name	Graft Insertion Instrument For Endothelial Keratoplasty
	Class	1
	Regulation Name	Intraocular lens guide
	Regulation No.	886.4300
	Identification	An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
	Status	510(k)
	Remarks	A graft insertion device for endothelial keratoplasty functions as a protective guide for the insertion of a donor corneal graft through a corneal incision. Once the graft tissue has been loaded into the insertion device, the device is inserted through the corneal incision in the subject’s eye. Once in the eye, the operator can then releases or dispenses the tissue graft from the device. Following graft release, the graft insertion device is removed.

NCE	Device Name	Injector, Capsular Tension Ring
	Class	1
	Regulation Name	Intraocular lens guide
	Regulation No.	886.4300
	Identification	An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
	Status	510(k)
	Remarks	NIL

KYB	Device Name	Lens, Guide, Intraocular
	Class	1
	Regulation Name	Intraocular lens guide
	Regulation No.	886.4300
	Identification	An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOF	Device Name	Burr, Corneal, Manual
	Class	1
	Regulation Name	Manual ophthalmic surgical instrument
	Regulation No.	886.4350
	Identification	A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOE	Device Name	Caliper, Ophthalmic
	Class	1
	Regulation Name	Manual ophthalmic surgical instrument
	Regulation No.	886.4350
	Identification	A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HMX	Device Name	Cannula, Ophthalmic
	Class	1
	Regulation Name	Manual ophthalmic surgical instrument
	Regulation No.	886.4350
	Identification	A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

MXY	Device Name	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
	Class	1
	Regulation Name	Manual ophthalmic surgical instrument
	Regulation No.	886.4350
	Identification	A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

NGY	Device Name	Cannula, Trocar, Ophthalmic
	Class	1
	Regulation Name	Manual ophthalmic surgical instrument
	Regulation No.	886.4350
	Identification	A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

QGJ	Device Name	Corneal Inlay Inserter Handle
	Class	1
	Regulation Name	Corneal inlay inserter handle.
	Regulation No.	886.4355
	Identification	A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

QGJ	Device Name	Corneal Inlay Inserter Handle
	Class	1
	Regulation Name	Corneal inlay inserter handle.
	Regulation No.	886.4355
	Identification	A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

KYG	Device Name	Device, Irrigation, Ocular Surgery
	Class	1
	Regulation Name	Ocular surgery irrigation device.
	Regulation No.	886.4360
	Identification	An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

FTZ	Device Name	Locator, Magnetic
	Class	1
	Regulation Name	Permanent magnet
	Regulation No.	886.4445.
	Identification	A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HPN	Device Name	Magnet, Permanent
	Class	1
	Regulation Name	Permanent magnet
	Regulation No.	886.4445.
	Identification	A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.
	Status	510(k) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

HMR	Device Name	Marker, Ocular
	Class	1
	Regulation Name	Ophthalmic surgical marker
	Regulation No.	886.4570
	Identification	An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HMQ	Device Name	Marker, Sclera
	Class	1
	Regulation Name	Ophthalmic surgical marker
	Regulation No.	886.4570
	Identification	An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HRP	Device Name	Pen, Marking, Surgical
	Class	1
	Regulation Name	Ophthalmic surgical marker
	Regulation No.	886.4570
	Identification	An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

MOE	Device Name	Collagen Corneal Shield
	Class	1
	Regulation Name	Ophthalmic eye shield
	Regulation No.	886.4750
	Identification	An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOY	Device Name	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
	Class	1
	Regulation Name	Ophthalmic eye shield
	Regulation No.	886.4750
	Identification	An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOH	Device Name	Spectacle, Operating (Loupe), Ophthalmic
	Class	1
	Regulation Name	Ophthalmic operating spectacles (loupes)
	Regulation No.	886.4770
	Identification	Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.
	Status	510(K) Exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HJH	Device Name	Loupe, Binocular, Low Power
	Class	1
	Regulation Name	Low-power binocular loupe
	Regulation No.	886.5120
	Identification	A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

KYE	Device Name	Inserter/Remover Contact Lens
	Class	1
	Regulation Name	Contact lens inserter/remover
	Regulation No.	886.5420
	Identification	A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HJF	Device Name	Magnifier, Hand-Held, Low-Vision
	Class	1
	Regulation Name	Low-vision magnifier
	Regulation No.	886.5540
	Identification	A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKC	Device Name	Spectacle Microscope, Low-Vision
	Class	1
	Regulation Name	Low-vision magnifier
	Regulation No.	886.5540
	Identification	A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HJZ	Device Name	Crutch, Ptosis
	Class	1
	Regulation Name	Ptosis crutch
	Regulation No.	886.5600
	Identification	A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HJY	Device Name	Reader, Bar, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic bar reader
	Regulation No.	886.5800.
	Identification	An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HJX	Device Name	Reader, prism, Ophthalmic
	Class	1
	Regulation Name	Ophthalmic prism reader.
	Regulation No.	886.5810
	Identification	An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

PLX	Device Name	Tear Duct Occluder
	Class	1
	Regulation Name	Nasolacrimal compression device
	Regulation No.	886.5838
	Identification	A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HOI	Device Name	Spectacle, Magnifying
	Class	1
	Regulation Name	Magnifying spectacles
	Regulation No.	886.5840.
	Identification	Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HQZ	Device Name	Frame, Spectacle
	Class	1
	Regulation Name	Spectacle frame.
	Regulation No.	886.5842
	Identification	A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

NAI	Device Name	Lens, Prescription, Color Deficiency
	Class	1
	Regulation Name	Prescription spectacle lens
	Regulation No.	886.5844
	Identification	A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

NJH	Device Name	Lens, Spectacle (Prescription), For Reading Discomfort
	Class	1
	Regulation Name	Prescription spectacle lens
	Regulation No.	886.5844
	Identification	A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HQG	Device Name	Lens, Spectacle, Non-Custom (Prescription)
	Class	1
	Regulation Name	Prescription spectacle lens
	Regulation No.	886.5844
	Identification	A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HQY	Device Name	Sunglasses (Non-Prescription Including Photosensitive)
	Class	1
	Regulation Name	Sunglasses (non-prescription)
	Regulation No.	886.5850
	Identification	Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKB	Device Name	Telescope, Hand-Held, Low-Vision
	Class	1
	Regulation Name	Low-vision telescope
	Regulation No.	886.5870
	Identification	A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

HKK	Device Name	Telescope, Spectacle, Low-Vision
	Class	1
	Regulation Name	Low-vision telescope
	Regulation No.	886.5870
	Identification	A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.
	Status	510(K) exempt
	Remarks	This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

OPHTHALMIC DEVICES

(Non-active Class II devices)

Product code
HJK	Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
	Class	2
	Regulation Name	Polymethylmethacrylate (PMMA) diagnostic contact lens
	Regulation No.	886.1385
	Identification	A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
	Status	510(k)
	Remarks	NIL

NYK	Device Name	Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
	Class	2
	Regulation Name	Polymethylmethacrylate (PMMA) diagnostic contact lens
	Regulation No.	886.1385
	Identification	A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
	Status	510(k)
	Remarks	NIL

HJJ	Device Name	Flexible diagnostic Fresnel lens.
	Class	2
	Regulation Name	Lens, Fresnel, Flexible, Diagnostic
	Regulation No.	886.1390
	Identification	A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the lens of the eye)
	Status	510(k)
	Remarks	NIL

PLZ	Device Name	Ocular Pattern Recorder
	Class	2
	Regulation Name	Diurnal pattern recorder system.
	Regulation No.	886.1925
	Identification	A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
	Status	510(k)
	Remarks	NIL

HLA	Device Name	Calibrator, Tonometer
	Class	2
	Regulation Name	Tonometer and accessories
	Regulation No.	886.1930
	Identification	A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
	Status	510(k)
	Remarks	NIL

HPK	Device Name	Tonograph
	Class	2
	Regulation Name	Tonometer and accessories
	Regulation No.	886.1930
	Identification	A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
	Status	510(k)
	Remarks	NIL

NJJ	Device Name	Tonometer, Analyzer, Ocular Blood Flow
	Class	2
	Regulation Name	Tonometer and accessories
	Regulation No.	886.1930
	Identification	A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
	Status	510(k)
	Remarks	Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product classificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.

HKY	Device Name	Tonometer, Manual
	Class	2
	Regulation Name	Tonometer and accessories
	Regulation No.	886.1930
	Identification	A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
	Status	510(k)
	Remarks	NIL

HQW	Device Name	Clip, Tantalum, Ophthalmic
	Class	2
	Regulation Name	Ophthalmic tantalum clip
	Regulation No.	886.3100
	Identification	An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.
	Status	510(k) exempt
	Remarks	Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

HQN	Device Name	Conformer, Ophthalmic
	Class	2
	Regulation Name	Ophthalmic conformer
	Regulation No.	886.3130.
	Identification	An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
	Status	510(k) exempt
	Remarks	Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

NQB	Device Name	Conformer, Ophthalmic, Biological Tissue
	Class	2
	Regulation Name	Ophthalmic conformer
	Regulation No.	886.3130.
	Identification	An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
	Status	510(k) exempt
	Remarks	The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures. Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

NXM	Device Name	Prosthesis, Eyelid Spacer/Graft, Biologic
	Class	2
	Regulation Name	Ophthalmic conformer
	Regulation No.	886.3130
	Identification	An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
	Status	510(k) exempt
	Remarks	Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

NFM	Device Name	Expander, Tissue, Orbital
	Class	2
	Regulation Name	Eye sphere implant
	Regulation No.	886.3320.
	Identification	An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
	Status	510(k)
	Remarks	NIL

HPZ	Device Name	Implant, Eye Sphere
	Class	2
	Regulation Name	Eye sphere implant
	Regulation No.	886.3320.
	Identification	An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
	Status	510(k)
	Remarks	NIL

MQU	Device Name	Ocular Peg
	Class	2
	Regulation Name	Eye sphere implant
	Regulation No.	886.3320.
	Identification	An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
	Status	510(k)
	Remarks	NIL

PUF	Device Name	Ocular Peg, Exempt
	Class	2
	Regulation Name	Eye sphere implant
	Regulation No.	886.3320.
	Identification	An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
	Status	510(k) exempt
	Remarks	Exemption is limited to ocular pegs supplied sterile. This product code is the class II exempt counterpart of MQU, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

HQX	Device Name	Implant, Orbital, Extra-Ocular
	Class	2
	Regulation Name	Extraocular orbital implant
	Regulation No.	886.3340
	Identification	An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
	Status	510(k)
	Remarks	NIL

HQM	Device Name	Keratoprosthesis, Permanent Implant
	Class	2
	Regulation Name	Keratoprosthesis
	Regulation No.	886.3400
	Identification	A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
	Status	510(k)
	Remarks	NIL

MLP	Device Name	Keratoprosthesis, Temporary Implant, Surgical Use
	Class	2
	Regulation Name	Keratoprosthesis
	Regulation No.	886.3400
	Identification	A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
	Status	510(k)
	Remarks	NIL

HQT	Device Name	Shell, Scleral
	Class	2
	Regulation Name	Scleral shell
	Regulation No.	886.3800
	Identification	A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.
	Status	510(k) exempt
	Remarks	Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

KYF	Device Name	Implant, Eye Valve
	Class	2
	Regulation Name	Aqueous shunt
	Regulation No.	886.3920
	Identification	An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.
	Status	510(k)
	Remarks	NIL

LCC	Device Name	Applicator, Ocular Pressure
	Class	2
	Regulation Name	Ocular pressure applicator
	Regulation No.	886.4610
	Identification	An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery
	Status	510(K)
	Remarks	NIL

OJK	Device Name	Eye Tray
	Class	2
	Regulation Name	Ophthalmic sponge
	Regulation No.	886.4790
	Identification	An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.
	Status	510(K) Exempt
	Remarks	This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

HOZ	Device Name	Sponge, Ophthalmic
	Class	2
	Regulation Name	Ophthalmic sponge
	Regulation No.	886.4790
	Identification	An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.
	Status	510(K) Exempt
	Remarks	This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

HRL	Device Name	Unit, Beta, Radiation, Ophthalmic
	Class	2
	Regulation Name	Ophthalmic beta radiation source
	Regulation No.	886.5100
	Identification	An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
	Status	510(K)
	Remarks	NIL

MML	Device Name	Weights, Eyelid, External
	Class	2
	Regulation Name	Eyelid weight
	Regulation No.	886.5700
	Identification	An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).
	Status	510(K)
	Remarks	NIL

MUW	Device Name	Lens, Contact (Orthokeratology)
	Class	2* or 3#
	Regulation Name	Rigid gas permeable contact lens
	Regulation No.	886.5916.
	Identification	A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
	Status	510(K)
	Remarks	* Class II if the device is intended for daily wear only. # Class III if the device is intended for extended wear.

HQD	Device Name	Lens, Contact (Other Material) – Daily
	Class	2* or 3#
	Regulation Name	Rigid gas permeable contact lens
	Regulation No.	886.5916.
	Identification	A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
	Status	510(K)
	Remarks	* Class II if the device is intended for daily wear only. # Class III if the device is intended for extended wear.

MRC	Device Name	Products, Contact Lens Care, Rigid Gas Permeable
	Class	2
	Regulation Name	Rigid gas permeable contact lens care products.
	Regulation No.	886.5918
	Identification	A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.
	Status	510(K)
	Remarks	NIL

MVN	Device Name	Lens, Contact, (Disposable)
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens.
	Regulation No.	886.5925
	Identification	A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
	Status	510(K)
	Remarks	NIL

NCZ	Device Name	Lens, Contact, (Disposable Lens, Contact, For Color Vision Deficiency)
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens.
	Regulation No.	886.5925
	Identification	A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
	Status	510(K)
	Remarks	NIL

NIZ	Device Name	Lens, Contact, For Reading Discomfort
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens.
	Regulation No.	886.5925
	Identification	A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
	Status	510(K)
	Remarks	NIL

LPL	Device Name	Lenses, Soft Contact, Daily Wear
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens.
	Regulation No.	886.5925
	Identification	A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
	Status	510(K)
	Remarks	NIL

LPL	Device Name	Lenses, Soft Contact, Daily Wear
	Class	2* or 3#
	Regulation Name	Soft (hydrophilic) contact lens.
	Regulation No.	886.5925
	Identification	A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
	Status	510(K)
	Remarks	* Class II if the device is intended for daily wear only. # Class III if the device is intended for extended wear.

LPN	Device Name	Accessories, Soft Lens Products
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens care products
	Regulation No.	886.5928
	Identification	A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
	Status	510(K)
	Remarks	NIL

LYL	Device Name	Accessories, Solution, Ultrasonic Cleaners For Lenses
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens care products
	Regulation No.	886.5928
	Identification	A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
	Status	510(K)
	Remarks	NIL

LRX	Device Name	Case, Contact Lens
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens care products
	Regulation No.	886.5928
	Identification	A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
	Status	510(K)
	Remarks	NIL

LRX	Device Name	Case, Contact Lens
	Class	2
	Regulation Name	Soft (hydrophilic) contact lens care products
	Regulation No.	886.5928
	Identification	A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
	Status	510(K)
	Remarks	NIL

Ophthalmic Device FDA Registration

(Non-active Class I Medical Devices)

OPHTHALMIC DEVICES

(Non-active Class II devices)

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