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

5106

Total

5088

Cleared

170d

Avg (2y)

1976

Since

1303 Ophthalmic devices

576–600 of 1303

Cleared Jul 23, 2004

LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS

K041138 · CooperVision, Inc.

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

Cleared Jun 23, 2004

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

K041546 · Canon, Inc.

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

Cleared Mar 22, 2004

ZYOPTIX XP MICROKERATOME

K040204 · Bausch & Lomb, Inc.

HNO · Keratome, Ac-powered · 53d

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 Feb 10, 2004

MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK

K033941 · Bausch & Lomb, Inc.

HQF · Laser, Ophthalmic · 53d

Cleared Feb 02, 2004

AQUIFY MULTI-PURPOSE SOLUTION

K033608 · Ciba Vision Corporation

LPN · Accessories, Soft Lens Products · 77d

Cleared Dec 17, 2003

VENTURI PHACO PACK

K033653 · Bausch & Lomb, Inc.

HQC · Unit, Phacofragmentation · 26d

Cleared Dec 15, 2003

FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES

K033701 · Ciba Vision Corporation

MVN · Lens, Contact, (disposable) · 20d

Cleared Dec 04, 2003

NON-CONTACT TONOMETER, MODEL NT-4000

K031733 · Nidek, Inc.

HKX · Tonometer, Ac-powered · 183d

Cleared Nov 26, 2003

KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004

K032087 · Keeler Instruments, Inc.

HLJ · Ophthalmoscope, Battery-powered · 142d

Cleared Nov 14, 2003

BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03

K031646 · Bausch & Lomb, Inc.

LPN · Accessories, Soft Lens Products · 170d

Cleared Nov 07, 2003

PROCLEAR COMPATIBLES MULTIFOCAL

K032873 · CooperVision, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 53d

Cleared Oct 20, 2003

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

K032978 · Ciba Vision Corporation

HNO · Keratome, Ac-powered · 26d

Cleared Sep 12, 2003

AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K030522 · Ciba Vision Corporation

LPN · Accessories, Soft Lens Products · 205d

Cleared Aug 21, 2003

CENTURION SES EPIKERATOME

K031735 · Ciba Vision Corporation

HNO · Keratome, Ac-powered · 78d

Cleared Aug 14, 2003

MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION

K031957 · Ciba Vision Corporation

LPN · Accessories, Soft Lens Products · 50d

Cleared Aug 11, 2003

K031548 · Welch Allyn, Inc.

FSR · Light, Headband, Surgical · 87d

Cleared Aug 11, 2003

SOLID STATE LAMP [LED] HEADLIGHT

K031549 · Welch Allyn, Inc.

FSR · Light, Headband, Surgical · 87d

Cleared Jun 27, 2003

AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K031521 · Ciba Vision Corporation

LPN · Accessories, Soft Lens Products · 43d

Cleared Jun 27, 2003

SOLO-CARE PLUS MULTIPURPOSE SOLUTION

K031522 · Ciba Vision Corporation

LPN · Accessories, Soft Lens Products · 43d

Cleared Jun 06, 2003

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

K031629 · Canon USA, Inc.

HKI · Camera, Ophthalmic, Ac-powered · 10d

Cleared Feb 28, 2003

AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K023455 · Ciba Vision Corporation

MRC · Products, Contact Lens Care, Rigid Gas Permeable · 136d

Cleared Jan 27, 2003

LID CHAIN EYELID WEIGHTS

K021750 · Jedmed Instrument Co.

MML · Weights, Eyelid, External · 244d

Cleared Dec 10, 2002

CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K023732 · Ciba Vision Corporation

LPL · Lenses, Soft Contact, Daily Wear · 34d

Cleared Nov 19, 2002

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

K013694 · Nidek, Inc.

NFJ · System, Image Management, Ophthalmic · 377d

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