Subpart A - General Provisions

§ 886.1 - Scope.

§ 886.3 - Effective dates of requirement for premarket approval.

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

Subpart B - Diagnostic Devices

§ 886.1040 - Ocular esthesiometer.

§ 886.1050 - Adaptometer (biophotometer).

§ 886.1070 - Anomaloscope.

§ 886.1090 - Haidinger brush.

§ 886.1100 - Retinal diagnostic software device.

§ 886.1120 - Ophthalmic camera.

§ 886.1140 - Ophthalmic chair.

§ 886.1150 - Visual acuity chart.

§ 886.1160 - Color vision plate illuminator.

§ 886.1170 - Color vision tester.

§ 886.1190 - Distometer.

§ 886.1200 - Optokinetic drum.

§ 886.1220 - Corneal electrode.

§ 886.1250 - Euthyscope.

§ 886.1270 - Exophthalmometer.

§ 886.1290 - Fixation device.

§ 886.1300 - Afterimage flasher.

§ 886.1320 - Fornixscope.

§ 886.1330 - Amsler grid.

§ 886.1340 - Haploscope.

§ 886.1342 - Strabismus detection device.

§ 886.1350 - Keratoscope.

§ 886.1360 - Visual field laser instrument.

§ 886.1375 - Bagolini lens.

§ 886.1380 - Diagnostic condensing lens.

§ 886.1385 - Polymethylmethacrylate (PMMA) diagnostic contact lens.

§ 886.1390 - Flexible diagnostic Fresnel lens.

§ 886.1395 - Diagnostic Hruby fundus lens.

§ 886.1400 - Maddox lens.

§ 886.1405 - Ophthalmic trial lens set.

§ 886.1410 - Ophthalmic trial lens clip.

§ 886.1415 - Ophthalmic trial lens frame.

§ 886.1420 - Ophthalmic lens gauge.

§ 886.1425 - Lens measuring instrument.

§ 886.1430 - Ophthalmic contact lens radius measuring device.

§ 886.1435 - Maxwell spot.

§ 886.1450 - Corneal radius measuring device.

§ 886.1460 - Stereopsis measuring instrument.

§ 886.1500 - Headband mirror.

§ 886.1510 - Eye movement monitor.

§ 886.1570 - Ophthalmoscope.

§ 886.1605 - Perimeter.

§ 886.1630 - AC-powered photostimulator.

§ 886.1640 - Ophthalmic preamplifier.

§ 886.1650 - Ophthalmic bar prism.

§ 886.1655 - Ophthalmic Fresnel prism.

§ 886.1660 - Gonioscopic prism.

§ 886.1665 - Ophthalmic rotary prism.

§ 886.1670 - Ophthalmic isotope uptake probe.

§ 886.1680 - Ophthalmic projector.

§ 886.1690 - Pupillograph.

§ 886.1700 - Pupillometer.

§ 886.1750 - Skiascopic rack.

§ 886.1760 - Ophthalmic refractometer.

§ 886.1770 - Manual refractor.

§ 886.1780 - Retinoscope.

§ 886.1790 - Nearpoint ruler.

§ 886.1800 - Schirmer strip.

§ 886.1810 - Tangent screen (campimeter).

§ 886.1840 - Simulatan (including crossed cylinder).

§ 886.1850 - AC-powered slitlamp biomicroscope.

§ 886.1860 - Ophthalmic instrument stand.

§ 886.1870 - Stereoscope.

§ 886.1880 - Fusion and stereoscopic target.

§ 886.1905 - Nystagmus tape.

§ 886.1910 - Spectacle dissociation test system.

§ 886.1925 - Diurnal pattern recorder system.

§ 886.1930 - Tonometer and accessories.

§ 886.1940 - Tonometer sterilizer.

§ 886.1945 - Transilluminator.

Subpart C - XXX

Subpart D - Prosthetic Devices

§ 886.3100 - Ophthalmic tantalum clip.

§ 886.3130 - Ophthalmic conformer.

§ 886.3200 - Artificial eye.

§ 886.3300 - Absorbable implant (scleral buckling method).

§ 886.3320 - Eye sphere implant.

§ 886.3340 - Extraocular orbital implant.

§ 886.3400 - Keratoprosthesis.

§ 886.3600 - Intraocular lens.

§ 886.3800 - Scleral shell.

§ 886.3920 - Aqueous shunt.

Subpart E - Surgical Devices

§ 886.4070 - Powered corneal burr.

§ 886.4100 - Radiofrequency electrosurgical cautery apparatus.

§ 886.4115 - Thermal cautery unit.

§ 886.4150 - Vitreous aspiration and cutting instrument.

§ 886.4155 - Scleral plug.

§ 886.4170 - Cryophthalmic unit.

§ 886.4230 - Ophthalmic knife test drum.

§ 886.4250 - Ophthalmic electrolysis unit.

§ 886.4270 - Intraocular gas.

§ 886.4275 - Intraocular fluid.

§ 886.4280 - Intraocular pressure measuring device.

§ 886.4300 - Intraocular lens guide.

§ 886.4335 - Operating headlamp.

§ 886.4350 - Manual ophthalmic surgical instrument.

§ 886.4355 - xxx

§ 886.4360 - Ocular surgery irrigation device.

§ 886.4370 - Keratome.

§ 886.4390 - Ophthalmic laser.

§ 886.4392 - Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.

§ 886.4400 - Electronic metal locator.

§ 886.4440 - AC-powered magnet.

§ 886.4445 - Permanent magnet.

§ 886.4570 - Ophthalmic surgical marker.

§ 886.4610 - Ocular pressure applicator.

§ 886.4670 - Phacofragmentation system.

§ 886.4690 - Ophthalmic photocoagulator.

§ 886.4750 - Ophthalmic eye shield.

§ 886.4770 - Ophthalmic operating spectacles (loupes).

§ 886.4790 - Ophthalmic sponge.

§ 886.4855 - Ophthalmic instrument table.

Subpart F - Therapeutic Devices

§ 886.5100 - Ophthalmic beta radiation source.

§ 886.5120 - Low-power binocular loupe.

§ 886.5200 - Eyelid thermal pulsation system.

§ 886.5201 - Intense pulsed light device for managing dry eye.

§ 886.5300 - Tear electrostimulation device.

§ 886.5305 - Electromechanical tear stimulator.

§ 886.5310 - Intranasal electrostimulation device for dry eye symptoms.

§ 886.5350 - Ultrasound cyclodestructive device.

§ 886.5420 - Contact lens inserter/remover.

§ 886.5540 - Low-vision magnifier.

§ 886.5600 - Ptosis crutch.

§ 886.5700 - Eyelid weight.

§ 886.5800 - Ophthalmic bar reader.

§ 886.5810 - Ophthalmic prism reader.

§ 886.5820 - Closed-circuit television reading system.

§ 886.5838 - Nasolacrimal compression device.

§ 886.5840 - Magnifying spectacles.

§ 886.5842 - Spectacle frame.

§ 886.5844 - Prescription spectacle lens.

§ 886.5850 - Sunglasses (nonprescription).

§ 886.5870 - Low-vision telescope.

§ 886.5900 - Electronic vision aid.

§ 886.5905 - Oral electronic vision aid.

§ 886.5910 - Image intensification vision aid.

§ 886.5915 - Optical vision aid.

§ 886.5916 - Rigid gas permeable contact lens.

§ 886.5918 - Rigid gas permeable contact lens care products.

§ 886.5925 - Soft (hydrophilic) contact lens.

§ 886.5928 - Soft (hydrophilic) contact lens care products.

§ 886.5933 - [Reserved]