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Electronic Code of Federal Regulations

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e-CFR Data is current as of July 18, 2014

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 886—OPHTHALMIC DEVICES

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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).
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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.
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Subpart C—[RESERVED]

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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.
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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.
§886.4360
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.
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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.
§886.5700
XXX
§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]


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