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

2776–2800 of 2907

Cleared Sep 21, 1981

LENSINE EXTRA STRENGTH CLEANER

K812433 · CooperVision, Inc.

HPX · Lens, Contact (polymethylmethacrylate) · 27d

Cleared Sep 18, 1981

SURFACE REPLACEMENT HIP PROSTHESIS

K811718 · Biomet, Inc.

KYB · Lens, Guide, Intraocular · 92d

Cleared Sep 18, 1981

ULTRASONIC TIPS

K812126 · CooperVision, Inc.

HQC · Unit, Phacofragmentation · 53d

Cleared Sep 08, 1981

PHOTOLITE AOLITE TINTOMATIC LENS

K812051 · American Optical Corp.

HQG · Lens, Spectacle, Non-custom (prescription) · 49d

Cleared Aug 31, 1981

CONTACT LENS CLEANER

K812172 · Alcon Laboratories

HPX · Lens, Contact (polymethylmethacrylate) · 32d

Cleared Aug 20, 1981

ETHICON LACRIMAL STENT

K812255 · Ethicon, Inc.

HNL · Probe, Lachrymal · 8d

Cleared Aug 18, 1981

SR-1V DATA PRINTER

K812063 · American Optical Corp.

HKO · Refractometer, Ophthalmic · 28d

Cleared Jul 31, 1981

OPHTHALMIC SCISSORS

K811245 · Keeler Instruments, Inc.

HNF · Scissors, Ophthalmic · 88d

Cleared Jul 16, 1981

K811117 · American Pharmaseal Div. Ahsc

Cleared Jun 26, 1981

ANIS LENS IMPLANT FORCEPS #2

K811658 · American V. Mueller

HNR · Forceps, Ophthalmic · 14d

Cleared Jun 16, 1981

ANIS GUIDING CANNULA

K811455 · American V. Mueller

HMX · Cannula, Ophthalmic · 25d

Cleared May 15, 1981

ANIS IRRIGATING SPATULA

K810937 · American V. Mueller

HND · Spatula, Ophthalmic · 38d

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 22, 1980

PRO-OPHTA STICKS

K802794 · Secol Co.

HOZ · Sponge, Ophthalmic · 48d

Cleared Dec 19, 1980

ABSELE* ABSORBABLE BONE SEALANT

K802881 · Ethicon, Inc.

Cleared Dec 17, 1980

POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)

K802651 · Chiron Vision Corp.

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

Cleared Dec 17, 1980

POROPLAST-EYE DRESSING

K802786 · Secol Co.

HOY · Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) · 43d

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 Sep 16, 1980

SLIT LAMP ATTACHMENT

K801877 · Cavitron Corp.

HQB · Photocoagulator And Accessories · 41d

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