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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 886OPHTHALMIC DEVICES
 

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.
   § 886.1120 - 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.
   § 886.1350 - 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.
   § 886.1930 - Tonometer and accessories.
   § 886.1940 - Tonometer sterilizer.
   § 886.1945 - Transilluminator.

Subpart C [Reserved]

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.
   § 886.4170 - 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.
   § 886.4360 - 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.
   § 886.5420 - Contact lens inserter/remover.
   § 886.5540 - Low-vision magnifier.
   § 886.5600 - Ptosis crutch.
   § 886.5800 - Ophthalmic bar reader.
   § 886.5810 - Ophthalmic prism reader.
   § 886.5820 - Closed-circuit television reading system.
   § 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.
   § 886.5910 - 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]

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

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