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

5110

Total

5092

Cleared

168d

Avg (2y)

1976

Since

2907 Ophthalmic devices

2801–2825 of 2907

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 Aug 04, 1980

SPAN-AID BRIDGING PILLOW SYSTEM

K801518 · Span-America Medical Systems, Inc.

HKX · Tonometer, Ac-powered · 34d

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 Apr 29, 1980

AUTO-FIELD D AUTOMATED VISUAL DETECTOR

K800722 · Cavitron Corp.

HPT · Perimeter, Automatic, Ac-powered · 28d

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 10, 1980

AMBLYOPIA TRAINER

K800112 · Life-Tech Instruments, Inc.

HPL · Device, Fixation, Ac-powered, Ophthalmic · 54d

Cleared Mar 03, 1980

CRAWFORD LACRIMAL INTUBATION SET

K800089 · Jedmed Instrument Co.

HNL · Probe, Lachrymal · 49d

Cleared Mar 03, 1980

SILASTIC SCLERAL SPONGE II W/CIRCLING BD

K800140 · Dow Corning Corp. Healthcare Industries Materials

HQX · Implant, Orbital, Extra-ocular · 42d

Cleared Feb 19, 1980

VISALENS ALL PURPOSE SOLUTION FOR LENS

K791523 · Pfizer, Inc.

HPX · Lens, Contact (polymethylmethacrylate) · 193d

Cleared Dec 11, 1979

KELMAN DIPSTICK

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

HOE · Caliper, Ophthalmic · 15d

Cleared Nov 20, 1979

VISALENS CONCENTRATED CLEANER CONT LENS

K791524 · Pfizer, Inc.

HPX · Lens, Contact (polymethylmethacrylate) · 102d

Cleared Nov 16, 1979

LIO-714 OPACITYMETER

K790526 · Laser Industries , Ltd.

HJL · Lens, Condensing, Diagnostic · 246d

Cleared Oct 30, 1979

VERI-VU LENSOMETER

K791521 · Intermedics, Inc.

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

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

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