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

3901–3925 of 5119

Cleared Jan 27, 1988

K874252 · Richmond Products, Inc.

HOQ · Grid, Amsler · 100d

Cleared Jan 26, 1988

OPACITY LENSMETER 701

K874355 · Intraoptics, Inc.

HKI · Camera, Ophthalmic, Ac-powered · 95d

Cleared Jan 26, 1988

GOOD LOOKS DAZZLERS

K875067 · Mel Appel

HQY · Sunglasses (non-prescription Including Photosensitive) · 48d

Cleared Jan 22, 1988

BIO-COR II COLLAGEN CORNEAL SHIELD

K874224 · Bausch & Lomb, Inc.

MOE · Collagen Corneal Shield · 98d

Cleared Jan 22, 1988

BIO-COR EXT COLLAGEN CORNEAL SHIELD

K874225 · Bausch & Lomb, Inc.

MOE · Collagen Corneal Shield · 98d

Cleared Jan 12, 1988

PATTERN DISCRIMINATION PERIMETER

K874336 · Lkc Technologies, Inc.

HPT · Perimeter, Automatic, Ac-powered · 82d

Cleared Jan 11, 1988

SUPERVISOR SUN GOGGLES(TM)

K873405 · Eye Communications, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 139d

Cleared Jan 11, 1988

THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.

K874250 · Richmond Products, Inc.

HLP · Target, Fusion And Stereoscopic · 84d

Cleared Jan 11, 1988

WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT

K874251 · Richmond Products, Inc.

HLP · Target, Fusion And Stereoscopic · 84d

Cleared Jan 11, 1988

SOLOS SINGLE USE TITANIUM TIP

K874334 · Solos Ophthalmology

HQC · Unit, Phacofragmentation · 81d

Cleared Jan 06, 1988

ZEISS VISULAS ARGON LASER

K874609 · Carl Zeiss, Inc.

HQF · Laser, Ophthalmic · 58d

Cleared Jan 04, 1988

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

K874367 · Spembly Medical , Ltd.

HQO · Unit, Cautery, Thermal, Ac-powered · 73d

Cleared Dec 29, 1987

CONFIRMATION TESTS

K873907 · Richmond Products, Inc.

HPC · Set, Lens, Trial, Ophthalmic · 95d

Cleared Dec 23, 1987

H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.

K873908 · Richmond Products, Inc.

HIT · Tester, Color Vision · 89d

Cleared Dec 23, 1987

OPHTHALMIC TIP & BLADE SCALPELS

K874057 · Myocure, Inc.

HNN · Knife, Ophthalmic · 79d

Cleared Dec 23, 1987

OCS 100 (OCULAR COMPARATOR SYSTEM)

K874220 · Ocular Instruments, Inc.

HJO · Biomicroscope, Slit-lamp, Ac-powered · 68d

Cleared Dec 23, 1987

MALIS SURGICAL LOUPES

K874845 · Valley Forge Scientific Corp.

HJH · Loupe, Binocular, Low Power · 29d

Cleared Dec 23, 1987

WOODLYN CLASSIC REFRACTOR, PHOROPTOR

K874900 · Woodlyn, Inc.

HKN · Refractor, Manual, Non-powered, Including Phoropter · 22d

Cleared Dec 23, 1987

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS

K874963 · Solway, Inc.

HNA · Spud, Ophthalmic · 21d

Cleared Dec 22, 1987

OPHTHALMIC DISPOSABLE BLADES

K874056 · Myocure, Inc.

HNN · Knife, Ophthalmic · 78d

Cleared Dec 11, 1987

ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)

K873914 · Richmond Products, Inc.

HPL · Device, Fixation, Ac-powered, Ophthalmic · 77d

Cleared Dec 11, 1987

'E' CUBE AND 'E' PAD

K873916 · Richmond Products, Inc.

HOX · Chart, Visual Acuity · 77d

Cleared Dec 08, 1987

RIGID-LENS CASE

K874657 · Sola Ophthalmics

LRX · Case, Contact Lens · 19d

Cleared Dec 02, 1987

PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15

K873911 · Richmond Products, Inc.

HIT · Tester, Color Vision · 68d

Cleared Dec 02, 1987

COLOR BOOK ILLUMINATOR STAND

K873913 · Richmond Products, Inc.

HJD · Illuminator, Color Vision Plate · 68d

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