21 C.F.R. PART 886--OPHTHALMIC DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 886--OPHTHALMIC DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| 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
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| Adaptometer (biophotometer).
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| Color vision plate illuminator.
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| Visual field laser instrument.
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| Diagnostic condensing lens.
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| Polymethylmethacrylate (PMMA) diagnostic contact lens.
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| Flexible diagnostic Fresnel lens.
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| Diagnostic Hruby fundus lens.
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| Ophthalmic trial lens set.
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| Ophthalmic trial lens clip.
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| Ophthalmic trial lens frame.
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| Lens measuring instrument.
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| Ophthalmic contact lens radius measuring device.
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| Corneal radius measuring device.
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| Stereopsis measuring instrument.
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| AC-powered photostimulator.
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| Ophthalmic Fresnel prism.
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| Ophthalmic isotope uptake probe.
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| Ophthalmic refractometer.
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| Tangent screen (campimeter).
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| Simulatan (including crossed cylinder).
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| AC-powered slitlamp biomicroscope.
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| Ophthalmic instrument stand.
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| Fusion and stereoscopic target.
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| Spectacle dissociation test system.
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| Tonometer and accessories.
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Subpart C--[RESERVED]
Subpart D--PROSTHETIC DEVICES
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| Ophthalmic tantalum clip.
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| Absorbable implant (scleral buckling method).
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| Extraocular orbital implant.
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Subpart E--SURGICAL DEVICES
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| Radiofrequency electrosurgical cautery apparatus.
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| Vitreous aspiration and cutting instrument.
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| Ophthalmic knife test drum.
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| Ophthalmic electrolysis unit.
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| Intraocular pressure measuring device.
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| Manual ophthalmic surgical instrument.
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| Ocular surgery irrigation device.
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| Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
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| Electronic metal locator.
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| Ophthalmic surgical marker.
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| Ocular pressure applicator.
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| Phacofragmentation system.
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| Ophthalmic photocoagulator.
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| Ophthalmic operating spectacles (loupes).
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| Ophthalmic instrument table.
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Subpart F--THERAPEUTIC DEVICES
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| Ophthalmic beta radiation source.
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| Low-power binocular loupe.
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| Contact lens inserter/remover.
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| Closed-circuit television reading system.
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| Prescription spectacle lens.
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| Sunglasses (nonprescription).
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| Image intensification vision aid.
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| Rigid gas permeable contact lens.
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| Rigid gas permeable contact lens care products.
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| Soft (hydrophilic) contact lens.
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| Soft (hydrophilic) contact lens care products.
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