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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 886--OPHTHALMIC DEVICES
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 | 886.1 | Scope. |
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| 886.3 | Effective dates of requirement for premarket approval. |
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| 886.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 886.1040 | Ocular esthesiometer. |
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| 886.1050 | Adaptometer (biophotometer). |
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| 886.1070 | Anomaloscope. |
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| 886.1090 | Haidlinger brush. |
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| 886.1120 | Opthalmic camera. |
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| 886.1140 | Ophthalmic chair. |
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| 886.1150 | Visual acuity chart. |
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| 886.1160 | Color vision plate illuminator. |
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| 886.1170 | Color vision tester. |
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| 886.1190 | Distometer. |
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| 886.1200 | Optokinetic drum. |
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| 886.1220 | Corneal electrode. |
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| 886.1250 | Euthyscope. |
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| 886.1270 | Exophthalmometer. |
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| 886.1290 | Fixation device. |
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| 886.1300 | Afterimage flasher. |
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| 886.1320 | Fornixscope. |
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| 886.1330 | Amsler grid. |
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| 886.1340 | Haploscope. |
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| 886.1350 | Keratoscope. |
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| 886.1360 | Visual field laser instrument. |
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| 886.1375 | Bagolini lens. |
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| 886.1380 | Diagnostic condensing lens. |
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| 886.1385 | Polymethylmethacrylate (PMMA) diagnostic contact lens. |
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| 886.1390 | Flexible diagnostic Fresnel lens. |
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| 886.1395 | Diagnostic Hruby fundus lens. |
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| 886.1400 | Maddox lens. |
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| 886.1405 | Ophthalmic trial lens set. |
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| 886.1410 | Ophthalmic trial lens clip. |
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| 886.1415 | Ophthalmic trial lens frame. |
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| 886.1420 | Ophthalmic lens gauge. |
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| 886.1425 | Lens measuring instrument. |
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| 886.1430 | Ophthalmic contact lens radius measuring device. |
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| 886.1435 | Maxwell spot. |
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| 886.1450 | Corneal radius measuring device. |
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| 886.1460 | Stereopsis measuring instrument. |
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| 886.1500 | Headband mirror. |
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| 886.1510 | Eye movement monitor. |
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| 886.1570 | Ophthalmoscope. |
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| 886.1605 | Perimeter. |
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| 886.1630 | AC-powered photostimulator. |
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| 886.1640 | Ophthalmic preamplifier. |
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| 886.1650 | Ophthalmic bar prism. |
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| 886.1655 | Ophthalmic Fresnel prism. |
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| 886.1660 | Gonioscopic prism. |
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| 886.1665 | Ophthalmic rotary prism. |
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| 886.1670 | Ophthalmic isotope uptake probe. |
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| 886.1680 | Ophthalmic projector. |
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| 886.1690 | Pupillograph. |
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| 886.1700 | Pupillometer. |
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| 886.1750 | Skiascopic rack. |
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| 886.1760 | Ophthalmic refractometer. |
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| 886.1770 | Manual refractor. |
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| 886.1780 | Retinoscope. |
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| 886.1790 | Nearpoint ruler. |
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| 886.1800 | Schirmer strip. |
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| 886.1810 | Tangent screen (campimeter). |
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| 886.1840 | Simulatan (including crossed cylinder). |
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| 886.1850 | AC-powered slitlamp biomicroscope. |
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| 886.1860 | Ophthalmic instrument stand. |
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| 886.1870 | Stereoscope. |
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| 886.1880 | Fusion and stereoscopic target. |
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| 886.1905 | Nystagmus tape. |
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| 886.1910 | Spectacle dissociation test system. |
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| 886.1930 | Tonometer and accessories. |
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| 886.1940 | Tonometer sterilizer. |
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| 886.1945 | Transilluminator. |
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| 886.3100 | Ophthalmic tantalum clip. |
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| 886.3130 | Ophthalmic conformer. |
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| 886.3200 | Artificial eye. |
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| 886.3300 | Absorbable implant (scleral buckling method). |
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| 886.3320 | Eye sphere implant. |
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| 886.3340 | Extraocular orbital implant. |
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| 886.3400 | Keratoprosthesis. |
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| 886.3600 | Intraocular lens. |
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| 886.3800 | Scleral shell. |
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| 886.3920 | Eye valve implant. |
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| 886.4070 | Powered corneal burr. |
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| 886.4100 | Radiofrequency electrosurgical cautery apparatus. |
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| 886.4115 | Thermal cautery unit. |
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| 886.4150 | Vitreous aspiration and cutting instrument. |
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| 886.4170 | Cryophthalmic unit. |
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| 886.4230 | Ophthalmic knife test drum. |
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| 886.4250 | Ophthalmic electrolysis unit. |
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| 886.4270 | Intraocular gas. |
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| 886.4275 | Intraocular fluid. |
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| 886.4280 | Intraocular pressure measuring device. |
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| 886.4300 | Intraocular lens guide. |
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| 886.4335 | Operating headlamp. |
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| 886.4350 | Manual ophthalmic surgical instrument. |
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| 886.4360 | Ocular surgery irrigation device. |
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| 886.4370 | Keratome. |
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| 886.4390 | Ophthalmic laser. |
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| 886.4392 | Nd:YAG laser for posterior capsulotomy. |
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| 886.4400 | Electronic metal locator. |
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| 886.4440 | AC-powered magnet. |
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| 886.4445 | Permanent magnet. |
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| 886.4570 | Ophthalmic surgical marker. |
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| 886.4610 | Ocular pressure applicator. |
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| 886.4670 | Phacofragmentation system. |
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| 886.4690 | Ophthalmic photocoagulator. |
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| 886.4750 | Ophthalmic eye shield. |
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| 886.4770 | Ophthalmic operating spectacles (loupes). |
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| 886.4790 | Ophthalmic sponge. |
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| 886.4855 | Ophthalmic instrument table. |
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| 886.5100 | Ophthalmic beta radiation source. |
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| 886.5120 | Low-power binocular loupe. |
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| 886.5420 | Contact lens inserter/remover. |
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| 886.5540 | Low-vision magnifier. |
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| 886.5600 | Ptosis crutch. |
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| 886.5800 | Ophthalmic bar reader. |
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| 886.5810 | Ophthalmic prism reader. |
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| 886.5820 | Closed-circuit television reading system. |
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| 886.5840 | Magnifying spectacles. |
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| 886.5842 | Spectacle frame. |
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| 886.5844 | Prescription spectacle lens. |
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| 886.5850 | Sunglasses (nonprescription). |
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| 886.5870 | Low-vision telescope. |
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| 886.5900 | Electronic vision aid. |
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| 886.5910 | Image intensification vision aid. |
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| 886.5915 | Optical vision aid. |
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| 886.5916 | Rigid gas permeable contact lens. |
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| 886.5918 | Rigid gas permeable contact lens care products. |
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| 886.5925 | Soft (hydrophilic) contact lens. |
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| 886.5928 | Soft (hydrophilic) contact lens care products. |
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