FDA Review Panel · OP

FDA 510(k) Ophthalmic Devices

FDA 510(k) Ophthalmic Devices - Regulatory Overview

FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.

Main categories:

Contact lenses - daily, extended wear, toric and multifocal lenses
Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps

5106

Total

5088

Cleared

170d

Avg (2y)

1976

Since

1303 Ophthalmic devices

1201–1225 of 1303

Cleared Jul 31, 1981

OPHTHALMIC SCISSORS

K811245 · Keeler Instruments, Inc.

HNF · Scissors, Ophthalmic · 88d

Cleared Jul 16, 1981

K811117 · American Pharmaseal Div. Ahsc

Cleared May 15, 1981

ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ

K811180 · American Optical Corp.

HOS · Projector, Ophthalmic · 17d

Cleared Apr 23, 1981

SR-IV PROGRAMMED SUBJECTIVE REFRACTOR

K802183 · American Optical Corp.

HKO · Refractometer, Ophthalmic · 226d

Cleared Feb 27, 1981

FOX EYE SHIELDS

K810098 · American Hospital Supply Corp.

HOY · Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) · 39d

Cleared Feb 04, 1981

FISHER-PICKERING INTRAOCULAR EYE MAGNET

K803194 · Storz Instrument Co.

HNR · Forceps, Ophthalmic · 50d

Cleared Dec 19, 1980

ABSELE* ABSORBABLE BONE SEALANT

K802881 · Ethicon, Inc.

Cleared Dec 17, 1980

CONCEPT CANALICULUS INTUBATION SET

K802845 · Concept, Inc.

HNL · Probe, Lachrymal · 35d

Cleared Dec 11, 1980

FIBER OPTIC HEADLIGHT #60-0765

K802769 · Aspen Laboratories, Inc.

FCT · Headlight, Fiberoptic Focusing · 38d

Cleared Dec 11, 1980

FIBER OPTIC HEADLIGHT #60-0766766

K802770 · Aspen Laboratories, Inc.

FCT · Headlight, Fiberoptic Focusing · 38d

Cleared Nov 12, 1980

AO NON-CONTACT II TONOMETER

K802419 · American Optical Corp.

HKX · Tonometer, Ac-powered · 37d

Cleared Aug 27, 1980

ASNIS GUIDED SCREW SYSTEMS

K801969 · Howmedica Corp.

HNC · Specula, Ophthalmic · 8d

Cleared Aug 13, 1980

MADDOX LENS SPATULA CAT. #7245

K801609 · Edward Weck, Inc.

HND · Spatula, Ophthalmic · 29d

Cleared Aug 13, 1980

A O CUSTOM II CHAIR AND STAND

K801638 · American Optical Corp.

HME · Chair, Ophthalmic, Ac-powered · 27d

Cleared Aug 12, 1980

MCCULLEY CONTINUOUS SUTURE TIGHTNER

K801608 · Edward Weck, Inc.

HND · Spatula, Ophthalmic · 28d

Cleared Jul 28, 1980

GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE

K801465 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 34d

Cleared Jul 28, 1980

LEIGH MEASURING SCALE #7725

K801466 · Edward Weck, Inc.

HLN · Gauge, Lens, Ophthalmic · 34d

Cleared Jul 28, 1980

DODICK LENS HOLDING FORCEPS

K801467 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 34d

Cleared Jul 28, 1980

BONN MICRO IRIS HOOK (NON-STERILE) #7613

K801469 · Edward Weck, Inc.

HNQ · Hook, Ophthalmic · 34d

Cleared Jun 17, 1980

JACKSON LACRIMAL INTUBATION SET

K801232 · Storz Instrument Co.

HNL · Probe, Lachrymal · 21d

Cleared Mar 12, 1980

K800192 · American Optical Corp.

HPX · Lens, Contact (polymethylmethacrylate) · 43d

Cleared Mar 12, 1980

OPHTHALMIC FORCEPS

K800368 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 21d

Cleared Mar 03, 1980

CRAWFORD LACRIMAL INTUBATION SET

K800089 · Jedmed Instrument Co.

HNL · Probe, Lachrymal · 49d

Cleared Dec 11, 1979

KELMAN DIPSTICK

K792383 · V. Mueller O.V. Baxter Healthcare Corp.

HOE · Caliper, Ophthalmic · 15d

Cleared Oct 30, 1979

VERI-VU LENSOMETER

K791521 · Intermedics, Inc.

HLM · Instrument, Measuring, Lens, Ac-powered · 81d

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