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FEDERAL · 21 CFR

Part 886 — Ophthalmic Devices

146 sections · Title 21: Food and Drugs

§ 886.1Scope.
§ 886.3Effective dates of requirement for premarket approval.
§ 886.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 886.1040Ocular esthesiometer.
§ 886.1050Adaptometer (biophotometer).
§ 886.1070Anomaloscope.
§ 886.1090Haidinger brush.
§ 886.1100Retinal diagnostic software device.
§ 886.1120Ophthalmic camera.
§ 886.1140Ophthalmic chair.
§ 886.1150Visual acuity chart.
§ 886.1160Color vision plate illuminator.
§ 886.1170Color vision tester.
§ 886.1190Distometer.
§ 886.1200Optokinetic drum.
§ 886.1220Corneal electrode.
§ 886.1250Euthyscope.
§ 886.1270Exophthalmometer.
§ 886.1290Fixation device.
§ 886.1300Afterimage flasher.
§ 886.1320Fornixscope.
§ 886.1330Amsler grid.
§ 886.1340Haploscope.
§ 886.1342Strabismus detection device.
§ 886.1350Keratoscope.
§ 886.1360Visual field laser instrument.
§ 886.1375Bagolini lens.
§ 886.1380Diagnostic condensing lens.
§ 886.1385Polymethylmethacrylate (PMMA) diagnostic contact lens.
§ 886.1390Flexible diagnostic Fresnel lens.
§ 886.1395Diagnostic Hruby fundus lens.
§ 886.1400Maddox lens.
§ 886.1405Ophthalmic trial lens set.
§ 886.1410Ophthalmic trial lens clip.
§ 886.1415Ophthalmic trial lens frame.
§ 886.1420Ophthalmic lens gauge.
§ 886.1425Lens measuring instrument.
§ 886.1430Ophthalmic contact lens radius measuring device.
§ 886.1435Maxwell spot.
§ 886.1450Corneal radius measuring device.
§ 886.1460Stereopsis measuring instrument.
§ 886.1500Headband mirror.
§ 886.1510Eye movement monitor.
§ 886.1570Ophthalmoscope.
§ 886.1605Perimeter.
§ 886.1630AC-powered photostimulator.
§ 886.1640Ophthalmic preamplifier.
§ 886.1650Ophthalmic bar prism.
§ 886.1655Ophthalmic Fresnel prism.
§ 886.1660Gonioscopic prism.
§ 886.1665Ophthalmic rotary prism.
§ 886.1670Ophthalmic isotope uptake probe.
§ 886.1680Ophthalmic projector.
§ 886.1690Pupillograph.
§ 886.1700Pupillometer.
§ 886.1750Skiascopic rack.
§ 886.1760Ophthalmic refractometer.
§ 886.1770Manual refractor.
§ 886.1780Retinoscope.
§ 886.1790Nearpoint ruler.
§ 886.1800Schirmer strip.
§ 886.1810Tangent screen (campimeter).
§ 886.1840Simulatan (including crossed cylinder).
§ 886.1850AC-powered slitlamp biomicroscope.
§ 886.1860Ophthalmic instrument stand.
§ 886.1870Stereoscope.
§ 886.1880Fusion and stereoscopic target.
§ 886.1905Nystagmus tape.
§ 886.1910Spectacle dissociation test system.
§ 886.1925Diurnal pattern recorder system.
§ 886.1930Tonometer and accessories.
§ 886.1940Tonometer sterilizer.
§ 886.1945Transilluminator.
§ 886.3100Ophthalmic tantalum clip.
§ 886.3130Ophthalmic conformer.
§ 886.3200Artificial eye.
§ 886.3300Absorbable implant (scleral buckling method).
§ 886.3320Eye sphere implant.
§ 886.3340Extraocular orbital implant.
§ 886.3400Keratoprosthesis.
§ 886.3600Intraocular lens.
§ 886.3800Scleral shell.
§ 886.3920Aqueous shunt.
§ 886.4070Powered corneal burr.
§ 886.4100Radiofrequency electrosurgical cautery apparatus.
§ 886.4115Thermal cautery unit.
§ 886.4150Vitreous aspiration and cutting instrument.
§ 886.4155Scleral plug.
§ 886.4170Cryophthalmic unit.
§ 886.4230Ophthalmic knife test drum.
§ 886.4250Ophthalmic electrolysis unit.
§ 886.4270Intraocular gas.
§ 886.4275Intraocular fluid.
§ 886.4280Intraocular pressure measuring device.
§ 886.4300Intraocular lens guide.
§ 886.4320Corneal storage medium with preservatives including antifungals.
§ 886.4335Operating headlamp.
§ 886.4350Manual ophthalmic surgical instrument.
§ 886.4355Corneal inlay inserter handle.
§ 886.4360Ocular surgery irrigation device.
§ 886.4370Keratome.
§ 886.4390Ophthalmic laser.
§ 886.4392Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
§ 886.4400Electronic metal locator.
§ 886.4440AC-powered magnet.
§ 886.4445Permanent magnet.
§ 886.4570Ophthalmic surgical marker.
§ 886.4610Ocular pressure applicator.
§ 886.4670Phacofragmentation system.
§ 886.4690Ophthalmic photocoagulator.
§ 886.4750Ophthalmic eye shield.
§ 886.4770Ophthalmic operating spectacles (loupes).
§ 886.4790Ophthalmic sponge.
§ 886.4855Ophthalmic instrument table.
§ 886.5100Ophthalmic beta radiation source.
§ 886.5120Low-power binocular loupe.
§ 886.5200Eyelid thermal pulsation system.
§ 886.5201Intense pulsed light device for managing dry eye.
§ 886.5300Tear electrostimulation device.
§ 886.5305Electromechanical tear stimulator.
§ 886.5310Intranasal electrostimulation device for dry eye symptoms.
§ 886.5350Ultrasound cyclodestructive device.
§ 886.5420Contact lens inserter/remover.
§ 886.5500Digital therapy device for amblyopia.
§ 886.5540Low-vision magnifier.
§ 886.5600Ptosis crutch.
§ 886.5700Eyelid weight.
§ 886.5800Ophthalmic bar reader. P&gt;(a) <em>Identification.</em> 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.
§ 886.5810Ophthalmic prism reader.
§ 886.5820Closed-circuit television reading system.
§ 886.5838Nasolacrimal compression device.
§ 886.5840Magnifying spectacles.
§ 886.5842Spectacle frame.
§ 886.5844Prescription spectacle lens.
§ 886.5850Sunglasses (nonprescription).
§ 886.5870Low-vision telescope.
§ 886.5900Electronic vision aid.
§ 886.5905Oral electronic vision aid.
§ 886.5910Image intensification vision aid.
§ 886.5915Optical vision aid.
§ 886.5916Rigid gas permeable contact lens.
§ 886.5918Rigid gas permeable contact lens care products.
§ 886.5919Hydrophilic re-coating solution.
§ 886.5925Soft (hydrophilic) contact lens.
§ 886.5928Soft (hydrophilic) contact lens care products.
§ 886.5933§ 886.5933 [Reserved]