Ophthalmic Device FDA Registration

Ocular esthesiometer

Regulation No.

886.1040

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

Chart, Visual Acuity

1

Visual acuity chart.

Regulation No.

886.1150

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

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

Tester, Color Vision

1

Color vision tester

Regulation No.

886.1170.

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.

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

Regulation No.

886.1190

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.

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

Drum, Opticokinetic

1

Optokinetic drum

Regulation No.

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.

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

Exophthalmometer.

1

Exophthalmometer.

Regulation No.

An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

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

Fornixscope

1

Fornixscope

Regulation No.

A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.

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

Grid, Amsler

Amsler grid

Regulation No.

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.

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.

Lens, Bagolini

1

Bagolini lens

Regulation No.

886.1375

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).

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

1

Regulation No.

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.

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

Lens, Fundus, Hruby, Diagnostic

Class

Regulation Name

Regulation No.

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.

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

Lens, Maddox

Class

Regulation Name

Regulation No.

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.

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

Set, Lens, Trial, Ophthalmic

Class

Regulation Name

Regulation No.

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.

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

Clip, Lens, Trial, Ophthalmic

Class

Regulation Name

Regulation No.

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.

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

Frame, Trial, Ophthalmic

Class

Regulation Name

Regulation No.

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.

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

Gauge, Lens, Ophthalmic

Class

Regulation Name

Regulation No.

An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.

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

Instrument, Measuring, Stereopsis

Class

Regulation Name

Regulation No.

A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.

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

Instrument, Measuring, Stereopsis

Class

Regulation Name

Regulation No.

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.

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

Prism, Bar, Ophthalmic

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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).

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

Class

Regulation Name

Regulation No.

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

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

886.3200

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.

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

Class

Regulation Name

Regulation No.

886.3200

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.

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

Class

Regulation Name

Regulation No.

886.3300

An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.

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

Class

Regulation Name

Ophthalmic knife test drum

Regulation No.

An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.

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

Class

Regulation Name

Intraocular lens guide

Regulation No.

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.

OTZ

Graft Insertion Instrument For Endothelial Keratoplasty

Class

Regulation Name

Intraocular lens guide

Regulation No.

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.

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

Class

Regulation Name

Intraocular lens guide

Regulation No.

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.

NIL

KYB

Class

Regulation Name

Intraocular lens guide

Regulation No.

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.

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

Class

Regulation Name

Manual ophthalmic surgical instrument

Regulation No.

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.

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

Class

Regulation Name

Manual ophthalmic surgical instrument

Regulation No.

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.

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

Class

Regulation Name

Manual ophthalmic surgical instrument

Regulation No.

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.

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

Class

Regulation Name

Manual ophthalmic surgical instrument

Regulation No.

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.

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

Class

Regulation Name

Manual ophthalmic surgical instrument

Regulation No.

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.

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

Class

Regulation Name

Corneal inlay inserter handle.

Regulation No.

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.

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

Class

Regulation Name

Corneal inlay inserter handle.

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

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

Class

Regulation Name

Regulation No.

A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

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.

Marker, Ocular

1

Ophthalmic surgical marker

Regulation No.

886.4570

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

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

1

Ophthalmic surgical marker

Regulation No.

886.4570

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

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

1

Ophthalmic surgical marker

Regulation No.

886.4570

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

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

1

Ophthalmic eye shield

Regulation No.

886.4750

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.

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

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

1

Ophthalmic eye shield

Regulation No.

886.4750

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.

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

Spectacle, Operating (Loupe), Ophthalmic

1

Ophthalmic operating spectacles (loupes)

Regulation No.

886.4770

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.

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

Loupe, Binocular, Low Power

1

Low-power binocular loupe

Regulation No.

886.5120

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.

510(K) exempt

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

Inserter/Remover Contact Lens

1

Contact lens inserter/remover

Regulation No.

886.5420

A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.

510(K) exempt

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

Magnifier, Hand-Held, Low-Vision

1

Low-vision magnifier

Regulation No.

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.

510(K) exempt

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

Spectacle Microscope, Low-Vision

1

Low-vision magnifier

Regulation No.

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.

510(K) exempt

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

Crutch, Ptosis

1

Ptosis crutch

Regulation No.

886.5600

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.

510(K) exempt

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

1

Ophthalmic bar reader

Regulation No.

886.5800.

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.

510(K) exempt

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

1

Ophthalmic prism reader.

Regulation No.

886.5810

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.

510(K) exempt

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

1

Nasolacrimal compression device

Regulation No.

886.5838

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.

510(K) exempt

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

1

Magnifying spectacles

Regulation No.

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.

510(K) exempt

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

1

Spectacle frame.

Regulation No.

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.

510(K) exempt

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

1

Prescription spectacle lens

Regulation No.

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.

510(K) exempt

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

1

Prescription spectacle lens

Regulation No.

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.

510(K) exempt

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

1

Prescription spectacle lens

Regulation No.

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.

510(K) exempt

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

1

Sunglasses (non-prescription)

Regulation No.

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.

510(K) exempt

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

Telescope, Hand-Held, Low-Vision

1

Low-vision telescope

Regulation No.

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.

510(K) exempt

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

Telescope, Spectacle, Low-Vision

1

Low-vision telescope

Regulation No.

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.

510(K) exempt

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

Lens, Contact, Polymethylmethacrylate, Diagnostic

Class

Regulation Name

Regulation No.

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.

NYK

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Class

Regulation Name

Regulation No.

886.1385

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.

Flexible diagnostic Fresnel lens.

Class

Regulation Name

Regulation No.

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)

PLZ

Class

Regulation Name

Regulation No.

NIL

HLA

Class

Regulation Name

Regulation No.

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.

NIL

HPK

Class

Regulation Name

Regulation No.

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.

NIL

NJJ

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

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.

NIL

HQW

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Regulation No.

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.

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

Class

Regulation Name

Ophthalmic conformer

Regulation No.

886.3130

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.

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

Class

Regulation Name

Eye sphere implant

Regulation No.

886.3320.

NIL

HPZ

Class

Regulation Name

Eye sphere implant

Regulation No.

886.3320.

NIL

MQU

Class

Regulation Name

Eye sphere implant

Regulation No.

886.3320.

NIL

PUF

Class

Regulation Name

Eye sphere implant

Regulation No.

886.3320.

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

Class

Regulation Name

Extraocular orbital implant

Regulation No.

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.

NIL

HQM

Class

Regulation Name

Keratoprosthesis

Regulation No.

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.

NIL

MLP

Class

Regulation Name

Keratoprosthesis

Regulation No.

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.

NIL

HQT

Class

Regulation Name

Scleral shell

Regulation No.

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.

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

Class

Regulation Name

Aqueous shunt

Regulation No.

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.

NIL

2

Ocular pressure applicator

Regulation No.

886.4610

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

Remarks

NIL

Eye Tray

2

Ophthalmic sponge

Regulation No.

886.4790

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.

510(K) Exempt

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.

Sponge, Ophthalmic

2

Ophthalmic sponge

Regulation No.

886.4790

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.

510(K) Exempt

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.

Unit, Beta, Radiation, Ophthalmic

2

Ophthalmic beta radiation source

Regulation No.

886.5100

An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.

510(K)

Weights, Eyelid, External

2

Eyelid weight

Regulation No.

886.5700

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).

510(K)

NIL

2*

or

3#

Rigid gas permeable contact lens

Regulation No.

886.5916.

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.

510(K)

* Class II if the device is intended for daily wear only.

# Class III if the device is intended for extended wear.

2*

or

3#

Rigid gas permeable contact lens

Regulation No.

886.5916.

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.

510(K)

* Class II if the device is intended for daily wear only.

# Class III if the device is intended for extended wear.

2

Rigid gas permeable contact lens care products.

Regulation No.

886.5918

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.

NIL

2

Soft (hydrophilic) contact lens.

Regulation No.

886.5925

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.

510(K)

NIL

2

Soft (hydrophilic) contact lens.

Regulation No.

886.5925

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.

510(K)

NIL

2

Soft (hydrophilic) contact lens.

Regulation No.

886.5925

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.

510(K)

NIL

2

Soft (hydrophilic) contact lens.

Regulation No.

886.5925

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.

510(K)

NIL

2*

or

3#

Soft (hydrophilic) contact lens.

Regulation No.

886.5925

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.

510(K)

* Class II if the device is intended for daily wear only.

# Class III if the device is intended for extended wear.

2

Soft (hydrophilic) contact lens care products

Regulation No.

886.5928

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.

510(K)

NIL

2

Regulation Name

Soft (hydrophilic) contact lens care products

Regulation No.

886.5928

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.

510(K)

NIL

2

Soft (hydrophilic) contact lens care products

Regulation No.

886.5928

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.

510(K)

NIL

2

Soft (hydrophilic) contact lens care products

Regulation No.

886.5928

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.

510(K)

NIL