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

2900 Ophthalmic devices

2376–2400 of 2900

Cleared May 22, 1987

MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC

K870839 · Directed Energy, Inc.

HQF · Laser, Ophthalmic · 86d

Cleared May 18, 1987

TANNE CORNEAL CUTTING BLOCK

K871646 · Ocular Instruments, Inc.

HNJ · Punch, Corneo-scleral · 20d

Cleared May 07, 1987

LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1

K871245 · Chiron Vision Corp.

LQJ · Lens, Surgical, Laser, Accesssory, Ophthalmic Laser · 41d

Cleared May 07, 1987

SITE PERISTALTIC MODULE SYSTEM

K871375 · Site Microsurgical Systems, Inc.

HQE · Instrument, Vitreous Aspiration And Cutting, Ac-powered · 30d

Cleared May 07, 1987

KRATZ NOVA-SERT

K871440 · CooperVision, Inc.

KYB · Lens, Guide, Intraocular · 24d

Cleared Apr 27, 1987

SCHIRMER NYLON SUTURE LASER LENS

K871099 · Ocular Instruments, Inc.

LQJ · Lens, Surgical, Laser, Accesssory, Ophthalmic Laser · 39d

Cleared Mar 20, 1987

LOOK RETROBULBAR NEEDLES

K870902 · Look, Inc.

HMX · Cannula, Ophthalmic · 15d

Cleared Mar 17, 1987

KEELER PULSAIR NON CONTACT TONOMETER

K870750 · Keeler Instruments, Inc.

HKX · Tonometer, Ac-powered · 20d

Cleared Feb 20, 1987

DIGILAB MODEL 1500 PERIMETER

K870120 · Bio-Rad

HPT · Perimeter, Automatic, Ac-powered · 39d

Cleared Feb 20, 1987

DIGILAB MICRO ONE APPLANATION TONOMETER

K870121 · Bio-Rad

HKX · Tonometer, Ac-powered · 39d

Cleared Feb 20, 1987

KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR

K870265 · CooperVision, Inc.

KYB · Lens, Guide, Intraocular · 28d

Cleared Feb 20, 1987

LOOK IRRIGATING/ASPIRATING CANNULAS

K870436 · Look, Inc.

HMX · Cannula, Ophthalmic · 17d

Cleared Feb 20, 1987

LOOK CAPSULE POLISHERS/SCRAPERS

K870437 · Look, Inc.

HNZ · Curette, Ophthalmic · 17d

Cleared Feb 20, 1987

LOOK IRRIGATING CANNULAS

K870438 · Look, Inc.

HMX · Cannula, Ophthalmic · 17d

Cleared Feb 20, 1987

LOOK IRRIGATING CYSTOTOMES

K870439 · Look, Inc.

HNY · Cystotome · 17d

Cleared Feb 20, 1987

LOOK LENS LOOPS

K870440 · Look, Inc.

HNQ · Hook, Ophthalmic · 17d

Cleared Feb 20, 1987

LOOK CORTEX EXTRACTORS

K870441 · Look, Inc.

HMX · Cannula, Ophthalmic · 17d

Cleared Feb 12, 1987

ASPIRATION REVERSAL CONTROL (ARC) MODULE

K870068 · Optical Micro Systems, Inc.

HQE · Instrument, Vitreous Aspiration And Cutting, Ac-powered · 35d

Cleared Feb 12, 1987

STORZ ENT/OPHTHALMIC MAXI CHAIR

K870112 · Storz Instrument Co.

HME · Chair, Ophthalmic, Ac-powered · 31d

Cleared Feb 12, 1987

KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5

K870203 · Keeler Instruments, Inc.

HKK · Telescope, Spectacle, Low-vision · 23d

Cleared Jan 20, 1987

K864726 · Ipax, Inc.

HQC · Unit, Phacofragmentation · 85d

Cleared Dec 29, 1986

REUSABLE SURGICAL KERATOSCOPE

K864639 · Jedmed Instrument Co.

HLR · Keratoscope, Battery-powered · 33d

Cleared Dec 15, 1986

BKS-42 DISPOSABLE VACUUM TUBING PACK

K864065 · Allergan, Inc.

HNO · Keratome, Ac-powered · 56d

Cleared Dec 15, 1986

RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE

K864290 · Keeler Instruments, Inc.

HNN · Knife, Ophthalmic · 45d

Cleared Dec 15, 1986

SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)

K864301 · Site Microsurgical Systems, Inc.

HQC · Unit, Phacofragmentation · 45d

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