Title 21, Part 886 — Ophthalmic Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Ocular esthesiometer.

Adaptometer (biophotometer).

Anomaloscope.

Haidinger brush.

Retinal diagnostic software device.

Ophthalmic camera.

Ophthalmic chair.

Visual acuity chart.

Color vision plate illuminator.

Color vision tester.

Distometer.

Optokinetic drum.

Corneal electrode.

Euthyscope.

Exophthalmometer.

Fixation device.

Afterimage flasher.

Fornixscope.

Amsler grid.

Haploscope.

Strabismus detection device.

Keratoscope.

Visual field laser instrument.

Bagolini lens.

Diagnostic condensing lens.

Polymethylmethacrylate (PMMA) diagnostic contact lens.

Flexible diagnostic Fresnel lens.

Diagnostic Hruby fundus lens.

Maddox lens.

Ophthalmic trial lens set.

Ophthalmic trial lens clip.

Ophthalmic trial lens frame.

Ophthalmic lens gauge.

Lens measuring instrument.

Ophthalmic contact lens radius measuring device.

Maxwell spot.

Corneal radius measuring device.

Stereopsis measuring instrument.

Headband mirror.

Eye movement monitor.

Ophthalmoscope.

Perimeter.

AC-powered photostimulator.

Ophthalmic preamplifier.

Ophthalmic bar prism.

Ophthalmic Fresnel prism.

Gonioscopic prism.

Ophthalmic rotary prism.

Ophthalmic isotope uptake probe.

Ophthalmic projector.

Pupillograph.

Pupillometer.

Skiascopic rack.

Ophthalmic refractometer.

Manual refractor.

Retinoscope.

Nearpoint ruler.

Schirmer strip.

Tangent screen (campimeter).

Simulatan (including crossed cylinder).

AC-powered slitlamp biomicroscope.

Ophthalmic instrument stand.

Stereoscope.

Fusion and stereoscopic target.

Nystagmus tape.

Spectacle dissociation test system.

Diurnal pattern recorder system.

Tonometer and accessories.

Tonometer sterilizer.

Transilluminator.

Ophthalmic tantalum clip.

Ophthalmic conformer.

Artificial eye.

Absorbable implant (scleral buckling method).

Eye sphere implant.

Extraocular orbital implant.

Keratoprosthesis.

Intraocular lens.

Scleral shell.

Aqueous shunt.

Powered corneal burr.

Radiofrequency electrosurgical cautery apparatus.

Thermal cautery unit.

Vitreous aspiration and cutting instrument.

Scleral plug.

Cryophthalmic unit.

Ophthalmic knife test drum.

Ophthalmic electrolysis unit.

Intraocular gas.

Intraocular fluid.

Intraocular pressure measuring device.

Intraocular lens guide.

Operating headlamp.

Manual ophthalmic surgical instrument.

Corneal inlay inserter handle.

Ocular surgery irrigation device.

Keratome.

Ophthalmic laser.

Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.

Electronic metal locator.

AC-powered magnet.

Permanent magnet.

Ophthalmic surgical marker.

Ocular pressure applicator.

Phacofragmentation system.

Ophthalmic photocoagulator.

Ophthalmic eye shield.

Ophthalmic operating spectacles (loupes).

Ophthalmic sponge.

Ophthalmic instrument table.

Ophthalmic beta radiation source.

Low-power binocular loupe.

Eyelid thermal pulsation system.

Intense pulsed light device for managing dry eye.

Tear electrostimulation device.

Electromechanical tear stimulator.

Intranasal electrostimulation device for dry eye symptoms.

Ultrasound cyclodestructive device.

Contact lens inserter/remover.

Low-vision magnifier.

Ptosis crutch.

Eyelid weight.

Ophthalmic bar reader. P>(a) 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.

Ophthalmic prism reader.

Closed-circuit television reading system.

Nasolacrimal compression device.

Magnifying spectacles.

Spectacle frame.

Prescription spectacle lens.

Sunglasses (nonprescription).

Low-vision telescope.

Electronic vision aid.

Oral electronic vision aid.

Image intensification vision aid.

Optical vision aid.

Rigid gas permeable contact lens.

Rigid gas permeable contact lens care products.

Hydrophilic re-coating solution.

Soft (hydrophilic) contact lens.

Soft (hydrophilic) contact lens care products.

[Reserved]