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

2891 Ophthalmic devices

1451–1475 of 2891

Cleared Jan 20, 1999

FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)

K982997 · Aspect Vision Care, Ltd.

LPL · Lenses, Soft Contact, Daily Wear · 146d

Cleared Jan 14, 1999

MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

K984575 · Alcon Laboratories

LPN · Accessories, Soft Lens Products · 22d

Cleared Jan 13, 1999

LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY

K982115 · Rim-Wide Companies, Inc.

LYL · Accessories, Solution, Ultrasonic Cleaners For Lenses · 211d

Cleared Jan 12, 1999

GOLDMAN MANUAL TONOMETER

K981432 · Golden Vision, Inc.

HKY · Tonometer, Manual · 267d

Cleared Jan 08, 1999

LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS

K983607 · Labtician Ophthalmics, Inc.

MML · Weights, Eyelid, External · 86d

Cleared Jan 06, 1999

PRECISION UV (VASURFILCON A)

K982988 · Wesley Jessen Corp.

LPL · Lenses, Soft Contact, Daily Wear · 133d

Cleared Dec 28, 1998

BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER

K982562 · Integrated Orbital Implants, Inc.

HPZ · Implant, Eye Sphere · 158d

Cleared Dec 22, 1998

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME

K980675 · Summit Technology, Inc.

HNO · Keratome, Ac-powered · 305d

Cleared Dec 22, 1998

MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)

K981554 · Micra Instruments , Ltd.

HNO · Keratome, Ac-powered · 235d

Cleared Dec 22, 1998

DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS

K982344 · Wesley Jessen Corp.

LPL · Lenses, Soft Contact, Daily Wear · 169d

Cleared Dec 22, 1998

BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS

K983773 · Benz Research and Development Corp.

LPL · Lenses, Soft Contact, Daily Wear · 57d

Cleared Dec 18, 1998

ML UNIVERSAL TUBING

K983448 · Med-Logics, Inc.

MSR · Tubing, Replacement, Phacofragmentation Unit · 79d

Cleared Dec 18, 1998

MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

K983780 · Alcon Laboratories

LPN · Accessories, Soft Lens Products · 52d

Cleared Dec 18, 1998

OPTI-ONE MULTI-PURPOSE SOLUTION

K983973 · Alcon Laboratories

LPN · Accessories, Soft Lens Products · 39d

Cleared Dec 18, 1998

ULTRACARE NEUTRALIZING TABLETS

K984383 · Allergan, Inc.

LPN · Accessories, Soft Lens Products · 10d

Cleared Dec 07, 1998

SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE

K981665 · Bio-Medical Sciences, Inc.

MMQ · Topographer, Corneal, Ac-powered · 210d

Cleared Dec 04, 1998

DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)

K983129 · Staar Surgical Co.

KYB · Lens, Guide, Intraocular · 87d

Cleared Dec 02, 1998

BARRON MICROKERATOME SYSTEM, MODEL B2000

K983317 · Barron Precision Instruments, LLC

HNO · Keratome, Ac-powered · 72d

Cleared Nov 25, 1998

COMPLETE BRAND LUBRICATING AND REWETTING DROPS

K983150 · Allergan, Inc.

LPN · Accessories, Soft Lens Products · 77d

Cleared Nov 25, 1998

OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)

K983278 · Alden Optical Labs., Inc.

LPL · Lenses, Soft Contact, Daily Wear · 69d

Cleared Nov 25, 1998

SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K983291 · Ciba Vision Corporation

MRC · Products, Contact Lens Care, Rigid Gas Permeable · 65d

Cleared Nov 18, 1998

BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS

K983894 · Bausch & Lomb, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 15d

Cleared Nov 17, 1998

SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K982168 · Ciba Vision Corporation

LPN · Accessories, Soft Lens Products · 151d

Cleared Nov 13, 1998

METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC

K983021 · Metrosoft, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 74d

Cleared Nov 06, 1998

POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR

K982110 · Optech, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 143d

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