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

1851–1875 of 5119

Cleared Feb 03, 1999

PANORAMIC200 OPTHALMOSCOPE

K983999 · Optos Plc.

HLI · Ophthalmoscope, Ac-powered · 86d

Cleared Jan 29, 1999

BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS

K982947 · Ocular Sciences Puerto Rico, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 161d

Cleared Jan 26, 1999

VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER

K983912 · Vistakon, Johnson & Johnson Vision Products, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 84d

Cleared Jan 25, 1999

FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS

K984273 · Ciba Vision Corporation

MVN · Lens, Contact, (disposable) · 56d

Cleared Jan 21, 1999

BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS

K984046 · Ocular Sciences Puerto Rico, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 70d

Cleared Jan 21, 1999

PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

K984259 · Cl-Tinters

LPL · Lenses, Soft Contact, Daily Wear · 52d

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

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