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

1351–1375 of 5119

Cleared Jul 02, 2004

VARILUX VISIONPRINT SYSTEM (VPS)

K033949 · Essilor Intl.

HLL · Monitor, Eye Movement · 196d

Cleared Jun 23, 2004

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

K041546 · Canon, Inc.

HKI · Camera, Ophthalmic, Ac-powered · 14d

Cleared Jun 22, 2004

ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA

K041108 · Iscience Surgical Corporation

MPA · Endoilluminator · 55d

Cleared Jun 18, 2004

M3 MICROKERATOME

K032836 · Moria SA

HNO · Keratome, Ac-powered · 281d

Cleared Jun 17, 2004

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

K040837 · Medicel AG

MSS · Folders And Injectors, Intraocular Lens (iol) · 78d

Cleared Jun 15, 2004

S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K040900 · Optical Connection, Inc.

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

Cleared Jun 10, 2004

RE-USEABLE MICROSTAAR INJECTOR, MSI-S

K032412 · Staar Surgical Co.

KYB · Lens, Guide, Intraocular · 310d

Cleared Jun 10, 2004

EYE SPHERE IMPLANTS

K040689 · Oculo Plastik, Inc.

HPZ · Implant, Eye Sphere · 86d

Cleared May 27, 2004

POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS

K040914 · Exero Products, Inc.

LRX · Case, Contact Lens · 49d

Cleared May 25, 2004

M2 COMPATIBLE MICROKERATOME BLADE

K033457 · Micro Specialties, Inc.

HNO · Keratome, Ac-powered · 208d

Cleared May 24, 2004

RTA MODEL D RETINAL THICKNESS ANALYZER

K041290 · Talia Technology , Ltd.

HLI · Ophthalmoscope, Ac-powered · 11d

Cleared Mar 31, 2004

ONEUSE- PLUS MICROKERATOME

K040297 · Moria SA

HMY · Keratome, Battery-powered · 51d

Cleared Mar 26, 2004

PRIZM KERATOME BLADE, MODEL MK8512M2

K033236 · Surgin Surgical Instrumentation, Inc.

HNO · Keratome, Ac-powered · 172d

Cleared Mar 22, 2004

ZYOPTIX XP MICROKERATOME

K040204 · Bausch & Lomb, Inc.

HNO · Keratome, Ac-powered · 53d

Cleared Mar 19, 2004

OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

K033594 · Contamac, Ltd.

HQD · Lens, Contact (other Material) - Daily · 127d

Cleared Mar 19, 2004

KERATO ANALYZER (EKA)

K040373 · Konan Medical, Inc.

NQE · Microscope, Specular · 31d

Cleared Mar 12, 2004

CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS

K033919 · Ciba Vision Corporation

LPL · Lenses, Soft Contact, Daily Wear · 85d

Cleared Mar 08, 2004

PANORET, MODEL PNM 60

K040325 · Medibell Medical Vision Technologies , Ltd.

HKI · Camera, Ophthalmic, Ac-powered · 27d

Cleared Mar 05, 2004

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2

K033136 · Innova Vision, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 157d

Cleared Feb 20, 2004

HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES

K031774 · Westcon Contact Lens Co., Inc.

LPL · Lenses, Soft Contact, Daily Wear · 256d

Cleared Feb 20, 2004

DORC VITRECTOMY LENSES, MODEL 1284 SERIES

K033950 · Dutch Ophthalmic Research Center (D.O.R.C.)

HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 60d

Cleared Feb 10, 2004

MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK

K033941 · Bausch & Lomb, Inc.

HQF · Laser, Ophthalmic · 53d

Cleared Feb 04, 2004

ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

K033969 · Vistakon

LPL · Lenses, Soft Contact, Daily Wear · 44d

Cleared Feb 02, 2004

AQUIFY MULTI-PURPOSE SOLUTION

K033608 · Ciba Vision Corporation

LPN · Accessories, Soft Lens Products · 77d

Cleared Feb 02, 2004

SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE

K033656 · Sauflon Pharmaceuticals, Ltd.

LRX · Case, Contact Lens · 73d

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