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

2001–2025 of 5119

Cleared Nov 21, 1997

K973193 · Luxtec Corp.

HQF · Laser, Ophthalmic · 88d

Cleared Nov 20, 1997

FLEXLENS, FLEXLENS TORIC

K973192 · Specialty Ultravision, Inc.

LPL · Lenses, Soft Contact, Daily Wear · 87d

Cleared Nov 20, 1997

AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS

K973597 · Martin Dalsing

LPL · Lenses, Soft Contact, Daily Wear · 59d

Cleared Nov 20, 1997

K974045 · Amsure Sports, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 27d

Cleared Nov 18, 1997

SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR

K973293 · Vaughan Weeks

MPA · Endoilluminator · 77d

Cleared Nov 18, 1997

K973934 · Elegance Optical Manufactory, Ltd.

HQY · Sunglasses (non-prescription Including Photosensitive) · 34d

Cleared Nov 14, 1997

SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK

K973290 · Vaughan Weeks

MPA · Endoilluminator · 73d

Cleared Nov 13, 1997

K973756 · Eyesys Technologies, Inc.

HLQ · Keratoscope, Ac-powered · 42d

Cleared Nov 07, 1997

D.O.R.C. SOLUX LIGHT SOURCE

K973757 · Dutch Ophthalmic USA, Inc.

MPA · Endoilluminator · 36d

Cleared Nov 04, 1997

K973218 · Nidek, Inc.

HKI · Camera, Ophthalmic, Ac-powered · 69d

Cleared Nov 04, 1997

RODENSTOCK LASER SLITLAMP

K973220 · G. Rodenstock Instrumente GmbH

HQF · Laser, Ophthalmic · 69d

Cleared Nov 04, 1997

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

K973533 · Nidek, Inc.

HKI · Camera, Ophthalmic, Ac-powered · 47d

Cleared Oct 24, 1997

HANSATOME MICROKERATOME

K972808 · Chiron Vision Corp.

HNO · Keratome, Ac-powered · 88d

Cleared Oct 16, 1997

MOA BONE / M-SPHERE

K972143 · Iop, Inc.

HPZ · Implant, Eye Sphere · 132d

Cleared Oct 16, 1997

K973526 · Pyramid Handbags, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 28d

Cleared Oct 15, 1997

(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI

K972807 · Benz Research and Development Corp.

LPL · Lenses, Soft Contact, Daily Wear · 79d

Cleared Oct 10, 1997

STORZ MILLENNIUM VISCOUS FLUID SYSTEM

K972664 · Storz Instrument Co.

MRH · Pump, Infusion, Ophthalmic · 86d

Cleared Oct 10, 1997

CBALK-1000 BLADE

K972727 · Howard Instruments, Inc.

HNO · Keratome, Ac-powered · 81d

Cleared Oct 03, 1997

LASEREX LP1532 PHOTOCOAGULATOR

K972514 · Ellex Medical Pty, Ltd.

HQF · Laser, Ophthalmic · 88d

Cleared Oct 03, 1997

EYE SPHERE, CONFORMERS

K972661 · Gulden Ophthalmics

HPZ · Implant, Eye Sphere · 79d

Cleared Oct 03, 1997

INNOVATOME MICROKERATOME

K973294 · Innovative Optics, Inc.

HNO · Keratome, Ac-powered · 31d

Cleared Oct 01, 1997

INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR

K972506 · Infinitech, Inc.

HJM · Transilluminator, Ac-powered · 90d

Cleared Sep 30, 1997

CATARACTSCREENER CT - S

K972440 · Neitz Instruments Company, Ltd.

HKI · Camera, Ophthalmic, Ac-powered · 92d

Cleared Sep 30, 1997

ML-DISPOSABLE PAK

K972522 · Med-Logics, Inc.

MSR · Tubing, Replacement, Phacofragmentation Unit · 85d

Cleared Sep 30, 1997

DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR

K972693 · Deroyal Industries, Inc.

HOZ · Sponge, Ophthalmic · 74d

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