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

1226–1250 of 1303

Cleared Oct 30, 1979

REPL. PISTON FOR TROUTMAN CORNEAL PUNCH

K791988 · Edward Weck, Inc.

HNJ · Punch, Corneo-scleral · 35d

Cleared Oct 23, 1979

ULTRAVUE BLENDED BIFOCAL LENS

K791721 · American Optical Corp.

HQG · Lens, Spectacle, Non-custom (prescription) · 54d

Cleared Oct 04, 1979

TOME'S #'S 1221,1222,1223,1314,6640,6642

K791980 · Edward Weck, Inc.

HNN · Knife, Ophthalmic · 9d

Cleared Oct 04, 1979

SWAN KNIFE NEEDLE 1.5MM CAT # 1170

K791981 · Edward Weck, Inc.

HNN · Knife, Ophthalmic · 9d

Cleared Oct 04, 1979

CANNULA'S CAT #'S 6636, 6624, 6625

K791982 · Edward Weck, Inc.

HMX · Cannula, Ophthalmic · 9d

Cleared Oct 04, 1979

SPATULA'S #'S 7618,7248,7240,7242,5108

K791983 · Edward Weck, Inc.

HND · Spatula, Ophthalmic · 9d

Cleared Oct 04, 1979

HOOKS #'S 7600,7602,7603,7616

K791985 · Edward Weck, Inc.

HNQ · Hook, Ophthalmic · 9d

Cleared Oct 04, 1979

FIX. & LENS FOR. #'S 3510,3512,3248,3795

K791986 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 9d

Cleared Sep 04, 1979

VITREOUS SUCTION/CUTTER

K791000 · Concept, Inc.

HKP · Instrument, Vitreous Aspiration And Cutting, Battery-powered · 98d

Cleared Aug 28, 1979

K790893 · Varian Assoc., Inc.

HKP · Instrument, Vitreous Aspiration And Cutting, Battery-powered · 112d

Cleared Aug 28, 1979

RAY-BAN SUN GLASSES

K791499 · Bausch & Lomb, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 26d

Cleared Aug 03, 1979

K791351 · Depuy, Inc.

KYB · Lens, Guide, Intraocular · 17d

Cleared Jul 24, 1979

B & L OPHTHALMIC INSTRUMENT STAND

K791104 · Bausch & Lomb, Inc.

HMF · Stand, Instrument, Ac-powered, Ophthalmic · 41d

Cleared Jul 24, 1979

B & L OPHTHALMIC CHAIR

K791105 · Bausch & Lomb, Inc.

HMF · Stand, Instrument, Ac-powered, Ophthalmic · 41d

Cleared Feb 26, 1979

FUL-VUE ASPHERIC CATARACT LENS

K790251 · American Optical Corp.

HQG · Lens, Spectacle, Non-custom (prescription) · 20d

Cleared Feb 13, 1979

NEEDLES, CANNULAS, CYSTOTOMES

K782169 · Visitec Co.

HMX · Cannula, Ophthalmic · 46d

Cleared Feb 12, 1979

BEAVER CATARACT CYROXTRACTOR

K781338 · Edward Weck, Inc.

HPS · Unit, Cryophthalmic · 192d

Cleared Feb 12, 1979

MODEL 556-01 CRYOEXTRACTOR

K790102 · Intermedics, Inc.

HPS · Unit, Cryophthalmic · 27d

Cleared Feb 12, 1979

K790243 · Visitec Co.

HMX · Cannula, Ophthalmic · 45d

Cleared Feb 12, 1979

K790244 · Visitec Co.

HNY · Cystotome · 45d

Cleared Feb 09, 1979

SURGICAL EYE SHIELD

K781960 · Concept, Inc.

HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 80d

Cleared Jan 26, 1979

K782118 · American Optical Corp.

HKN · Refractor, Manual, Non-powered, Including Phoropter · 30d

Cleared Dec 04, 1978

RULER, WECK SCOTT

K781715 · Edward Weck, Inc.

HOE · Caliper, Ophthalmic · 60d

Cleared Nov 03, 1978

CLINITEX VIS-X ASPIRATING ACCESSORY

K780852 · Varian Assoc., Inc.

HKP · Instrument, Vitreous Aspiration And Cutting, Battery-powered · 165d

Cleared Oct 24, 1978

BAYLOW VISUAL ACUITY TESTER

K781452 · Codman & Shurtleff, Inc.

HOX · Chart, Visual Acuity · 62d

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