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

5119

Total

5101

Cleared

169d

Avg (2y)

1976

Since

5119 Ophthalmic devices

5051–5075 of 5119

Cleared Dec 13, 1977

LAMP DELIVERY SYS.-PHOTOCOAGULATION

K772213 · Varian Assoc., Inc.

HQB · Photocoagulator And Accessories · 11d

Cleared Dec 13, 1977

OPHTHALMOSCOPE, BINOCULAR, INDIRECT

K772214 · Varian Assoc., Inc.

HLI · Ophthalmoscope, Ac-powered · 11d

Cleared Nov 30, 1977

K772168 · Robert B. Scott Ocularists of Florida, Inc.

HQN · Conformer, Ophthalmic · 22d

Cleared Nov 28, 1977

OCULAR CEREBRAL VASCULAR MONITOR

K772130 · Digilab, Inc.

HKY · Tonometer, Manual · 17d

Cleared Nov 16, 1977

LENSES, EYEGLASS, SAFETY

K772124 · Techsight Corp.

HQG · Lens, Spectacle, Non-custom (prescription) · 5d

Cleared Nov 15, 1977

PENTAX F.O.-IT OBSERVER SCOPE

K772055 · Pilling Co.

Cleared Nov 09, 1977

TROUTMAN CORNEAL PUNCH

K771866 · Edward Weck, Inc.

HRH · Trephine, Manual, Ophthalmic · 37d

Cleared Nov 09, 1977

71110 DESK CHARGER

K771900 · Welch Allyn, Inc.

HLS · Exophthalmometer · 34d

Cleared Nov 09, 1977

SUBJECTIVE REFRACTOR, MOSEL SR-111

K771914 · American Optical Corp.

HKO · Refractometer, Ophthalmic · 28d

Cleared Nov 09, 1977

K772024 · Gentex Corporation

HQG · Lens, Spectacle, Non-custom (prescription) · 14d

Cleared Nov 09, 1977

TECHSIGHT LENSES WITH ZUMA COATING

K772044 · Techsight Corp.

HQG · Lens, Spectacle, Non-custom (prescription) · 12d

Cleared Sep 28, 1977

K771711 · Berkeley Bio-Engineering

HQE · Instrument, Vitreous Aspiration And Cutting, Ac-powered · 16d

Cleared Sep 26, 1977

FRAGMATOME MODEL 820

K771644 · Berkeley Bio-Engineering

HQC · Unit, Phacofragmentation · 28d

Cleared Sep 12, 1977

IRRIGATION/ASPIRATION NEEDLE

K771416 · Concept, Inc.

HMX · Cannula, Ophthalmic · 42d

Cleared Jul 11, 1977

HOT TEMP CAUTERY

K771189 · Edward Weck, Inc.

HQP · Unit, Cautery, Thermal, Battery-powered · 10d

Cleared Jun 17, 1977

K770955 · M.R.M. Optics, Inc.

HQG · Lens, Spectacle, Non-custom (prescription) · 21d

Cleared Jun 17, 1977

LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS

K771003 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 15d

Cleared Jun 03, 1977

POMERANTZEFF EQUATOR PLUS CAMERA

K770888 · Medical Instrument Research Assoc., Inc.

HKI · Camera, Ophthalmic, Ac-powered · 18d

Cleared May 06, 1977

LENS, CONTACT, HARD

K770582 · Berea Contact Lens, Inc.

HPX · Lens, Contact (polymethylmethacrylate) · 39d

Cleared May 06, 1977

OPHTHALMOSCOPE, MODEL #11100

K770768 · Welch Allyn, Inc.

HLI · Ophthalmoscope, Ac-powered · 8d

Cleared Apr 28, 1977

INTRAOCULAR LENS

K770728 · Milton Roy Co. Analytical

Cleared Mar 14, 1977

LENS SET, MENTOR TRIAL

K770389 · Codman & Shurtleff, Inc.

HPC · Set, Lens, Trial, Ophthalmic · 14d

Cleared Feb 17, 1977

MEMLITE (PLASTIC EYEGLASS FRAMES)

K770221 · American Optical Corp.

HQZ · Frame, Spectacle · 14d

Cleared Feb 17, 1977

K770222 · Concept, Inc.

HNI · Retractor, Ophthalmic · 14d

Cleared Feb 14, 1977

NASO-LACRIMAL DUCT INSERT

K770194 · Concept, Inc.

HNL · Probe, Lachrymal · 14d

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