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

2026–2050 of 5119

Cleared Sep 30, 1997

SUNGLASSES (NON-PRESCRIPTION)

K973407 · Pacific Optical Co. , Ltd.

HQY · Sunglasses (non-prescription Including Photosensitive) · 21d

Cleared Sep 30, 1997

K973490 · Tong Yang Optical Co.

HQY · Sunglasses (non-prescription Including Photosensitive) · 15d

Cleared Sep 19, 1997

K971067 · Medical Instrument Development Laboratories, Inc.

MRH · Pump, Infusion, Ophthalmic · 179d

Cleared Sep 17, 1997

K972850 · Indoptica, S.A.

HQY · Sunglasses (non-prescription Including Photosensitive) · 47d

Cleared Sep 17, 1997

NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS

K973016 · Optimaxx Intl.

HQY · Sunglasses (non-prescription Including Photosensitive) · 35d

Cleared Sep 09, 1997

PUNCTUAL OCCLUDER

K972523 · Odyssey Medical, Inc.

LZU · Plug, Punctum · 64d

Cleared Aug 26, 1997

FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR

K973063 · Aspect Vision Care, Ltd.

LPL · Lenses, Soft Contact, Daily Wear · 8d

Cleared Aug 25, 1997

RUFF WORK EYEGEAR

K972717 · Ruff House, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 35d

Cleared Aug 22, 1997

MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS

K972443 · Menicon U.S.A., Inc.

HQD · Lens, Contact (other Material) - Daily · 53d

Cleared Aug 20, 1997

OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS

K972303 · Ocular Sciences Puerto Rico, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 62d

Cleared Aug 14, 1997

K971953 · Tomey Corporation USA

HJO · Biomicroscope, Slit-lamp, Ac-powered · 78d

Cleared Aug 08, 1997

OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

K972454 · Bausch & Lomb, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 38d

Cleared Aug 06, 1997

ENDOVIEW SPPHIRE LENS SET

K971853 · American Medical Devices, Inc.

HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 78d

Cleared Aug 01, 1997

INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER

K971950 · Infinitech, Inc.

HQF · Laser, Ophthalmic · 65d

Cleared Jul 31, 1997

BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL

K963512 · Benz Research and Development Corp.

HQD · Lens, Contact (other Material) - Daily · 335d

Cleared Jul 31, 1997

BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)

K963744 · Benz Research and Development Corp.

HQD · Lens, Contact (other Material) - Daily · 317d

Cleared Jul 31, 1997

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK

K971832 · M-Pact Worldwide Management Corp.

HOZ · Sponge, Ophthalmic · 73d

Cleared Jul 31, 1997

NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES

K972590 · Lbi U.S.A.

HQY · Sunglasses (non-prescription Including Photosensitive) · 20d

Cleared Jul 29, 1997

HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)

K971671 · Heidelberg Engineering

HLI · Ophthalmoscope, Ac-powered · 83d

Cleared Jul 29, 1997

VISTA UNIVERSAL HANDPIECE

K972252 · Odyssey Technologies, Inc.

HQC · Unit, Phacofragmentation · 43d

Cleared Jul 29, 1997

P3 UNIVERSAL PHACO HANDPIECE

K972253 · Odyssey Technologies, Inc.

HQC · Unit, Phacofragmentation · 43d

Cleared Jul 25, 1997

D'ARC EYE CARE SUNGLASSES

K972490 · M & R Dist.

HQY · Sunglasses (non-prescription Including Photosensitive) · 23d

Cleared Jul 21, 1997

MOMO DESIGN OR MOMO

K972416 · Momo U.S.A., Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 24d

Cleared Jul 15, 1997

CONFOCAL MICROSCOPE

K970414 · Con-S , Ltd.

HJO · Biomicroscope, Slit-lamp, Ac-powered · 173d

Cleared Jul 15, 1997

LL BI-FOCAL, DAILY WEAR CONTACT LENS

K971647 · Lombart Lenses, Ltd.

LPL · Lenses, Soft Contact, Daily Wear · 71d

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