FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Ocular esthesiometer.
    - Adaptometer (biophotometer).
    - Anomaloscope.
    - Haidinger brush.
    - Retinal diagnostic software device.
    - Ophthalmic camera.
    - Ophthalmic chair.
    - Visual acuity chart.
    - Color vision plate illuminator.
    - Color vision tester.
    - Distometer.
    - Optokinetic drum.
    - Corneal electrode.
 - Euthyscope.
    - Exophthalmometer.
    - Fixation device.
    - Afterimage flasher.
    - Fornixscope.
    - Amsler grid.
    - Haploscope.
    - Strabismus detection device.
    - Keratoscope.
    - Visual field laser instrument.
    - Bagolini lens.
    - Diagnostic condensing lens.
    - Polymethylmethacrylate (PMMA) diagnostic contact lens.
    - Flexible diagnostic Fresnel lens.
    - Diagnostic Hruby fundus lens.
    - Maddox lens.
    - Ophthalmic trial lens set.
    - Ophthalmic trial lens clip.
    - Ophthalmic trial lens frame.
    - Ophthalmic lens gauge.
    - Lens measuring instrument.
    - Ophthalmic contact lens radius measuring device.
    - Maxwell spot.
    - Corneal radius measuring device.
    - Stereopsis measuring instrument.
    - Headband mirror.
    - Eye movement monitor.
    - Ophthalmoscope.
    - Perimeter.
    - AC-powered photostimulator.
    - Ophthalmic preamplifier.
    - Ophthalmic bar prism.
    - Ophthalmic Fresnel prism.
    - Gonioscopic prism.
    - Ophthalmic rotary prism.
    - Ophthalmic isotope uptake probe.
    - Ophthalmic projector.
    - Pupillograph.
    - Pupillometer.
    - Skiascopic rack.
    - Ophthalmic refractometer.
    - Manual refractor.
    - Retinoscope.
    - Nearpoint ruler.

 - Schirmer strip.
    - Tangent screen (campimeter).
    - Simulatan (including crossed cylinder).
    - AC-powered slitlamp biomicroscope.
    - Ophthalmic instrument stand.
    - Stereoscope.
    - Fusion and stereoscopic target.
    - Nystagmus tape.
    - Spectacle dissociation test system.
    - Diurnal pattern recorder system.
    - Tonometer and accessories.
    - Tonometer sterilizer.
    - Transilluminator.

Subpart C [Reserved]

    - Ophthalmic tantalum clip.
    - Ophthalmic conformer.
    - Artificial eye.
    - Absorbable implant (scleral buckling method).
    - Eye sphere implant.
    - Extraocular orbital implant.
    - Keratoprosthesis.
    - Intraocular lens.
    - Scleral shell.
    - Aqueous shunt.

    - Powered corneal burr.
    - Radiofrequency electrosurgical cautery apparatus.
    - Thermal cautery unit.
    - Vitreous aspiration and cutting instrument.
    - Scleral plug.
    - Cryophthalmic unit.
    - Ophthalmic knife test drum.
    - Ophthalmic electrolysis unit.
    - Intraocular gas.
    - Intraocular fluid.
    - Intraocular pressure measuring device.
    - Intraocular lens guide.
    - Operating headlamp.
    - Manual ophthalmic surgical instrument.
    - Corneal inlay inserter handle.
    - Ocular surgery irrigation device.
    - Keratome.
    - Ophthalmic laser.
    - Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
    - Electronic metal locator.
    - AC-powered magnet.
    - Permanent magnet.
    - Ophthalmic surgical marker.
    - Ocular pressure applicator.
    - Phacofragmentation system.
    - Ophthalmic photocoagulator.
    - Ophthalmic eye shield.
    - Ophthalmic operating spectacles (loupes).
    - Ophthalmic sponge.
    - Ophthalmic instrument table.

    - Ophthalmic beta radiation source.
    - Low-power binocular loupe.
    - Eyelid thermal pulsation system.
    - Tear electrostimulation device.
    - Electromechanical tear stimulator.
    - Intranasal electrostimulation device for dry eye symptoms.
    - Contact lens inserter/remover.
    - Low-vision magnifier.
    - Ptosis crutch.
    - Eyelid weight.
    - Ophthalmic bar reader.
    - Ophthalmic prism reader.
    - Closed-circuit television reading system.
    - Nasolacrimal compression device.
    - Magnifying spectacles.
    - Spectacle frame.
    - Prescription spectacle lens.
    - Sunglasses (nonprescription).
    - Low-vision telescope.
    - Electronic vision aid.
    - Oral electronic vision aid.
    - Image intensification vision aid.
    - Optical vision aid.
    - Rigid gas permeable contact lens.
    - Rigid gas permeable contact lens care products.
    - Soft (hydrophilic) contact lens.
    - Soft (hydrophilic) contact lens care products.
   § 886.5933 - [Reserved]

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

Extracted from US.FDA