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

3076–3100 of 5119

Cleared Oct 18, 1993

K933865 · Hillman'S, the Eyecare Co., Inc.

HQZ · Frame, Spectacle · 70d

Cleared Oct 18, 1993

SPECTACLE FRAMES

K933891 · Euro Frame Design, Inc.

HQZ · Frame, Spectacle · 69d

Cleared Oct 18, 1993

ASICS SUNGLASSES

K933905 · Asics Tiger Corp.

HQY · Sunglasses (non-prescription Including Photosensitive) · 68d

Cleared Oct 18, 1993

ALDO'S OPTICAL FRAME COLLECTION

K933956 · Frontier Novelty, Inc.

HQZ · Frame, Spectacle · 67d

Cleared Oct 18, 1993

SPECTACLE FRAMES

K933991 · U.S. Optical

HQZ · Frame, Spectacle · 62d

Cleared Oct 18, 1993

SPECTACLE SUNGLASSES (NON-PERSCRIPTION)

K934034 · H.M.O. Optical, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 61d

Cleared Oct 18, 1993

SPECTACLE SUN GLASSES (NON PRESCRIPTION)

K934081 · South American Optical, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 59d

Cleared Oct 18, 1993

SPECTACLE FRAMES

K934082 · South American Optical, Inc.

HQZ · Frame, Spectacle · 59d

Cleared Oct 18, 1993

NON-PRESCRIPTION EYEGLASS FRAMES & SUNGLASSES VARIOUS STYLES

K934120 · Lux DE Paris, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 55d

Cleared Oct 15, 1993

K932504 · Rudolf Riester GmbH & Co. KG

HLJ · Ophthalmoscope, Battery-powered · 147d

Cleared Oct 13, 1993

K933453 · Fortuna Optical Factory , Ltd.

HQZ · Frame, Spectacle · 92d

Cleared Oct 07, 1993

ACTION MEDTEK/DENTEK EYEGLASSES

K925564 · Action Eyewear Corp.

HOY · Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) · 338d

Cleared Oct 06, 1993

ITEM # 754 HOT FLIP SHADES

K931389 · Ja-Ru, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 202d

Cleared Oct 06, 1993

SUNGLASSES AND OPTICAL FRAMES, CARBON AND METAL FRAMES

K932838 · Wonderful Optical Co., Ltd.

HQY · Sunglasses (non-prescription Including Photosensitive) · 117d

Cleared Oct 06, 1993

K933452 · Tae Han Optical Ent.

HQZ · Frame, Spectacle · 85d

Cleared Oct 04, 1993

SPECTACLE FRAMES

K934033 · H.M.O. Optical, Inc.

HQZ · Frame, Spectacle · 47d

Cleared Oct 04, 1993

OPTIKOS SHAMI, INC. SPECTACLE FRAMES

K934198 · Optikos Shami, Inc.

HQZ · Frame, Spectacle · 39d

Cleared Oct 01, 1993

ALIBI OPTICAL FRAMES AND SUNGLASSES

K925187 · Alibi Designs, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 352d

Cleared Oct 01, 1993

K925570 · De'Vons Products, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 332d

Cleared Oct 01, 1993

ITEM # 755 HOT SUNGLASSES

K931055 · South American Industrial Co.

HQY · Sunglasses (non-prescription Including Photosensitive) · 232d

Cleared Oct 01, 1993

K931408 · Sunnycraft Philippines, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 196d

Cleared Oct 01, 1993

FLOATER SUNGLASSES

K931431 · Floater Eyewear, Inc.

HQY · Sunglasses (non-prescription Including Photosensitive) · 193d

Cleared Oct 01, 1993

BRILLENERZEUGUNG POMBERGER OR MULTIPLE SUNGLASSES

K931910 · Brillenerzeugung Pomberger

HQY · Sunglasses (non-prescription Including Photosensitive) · 168d

Cleared Oct 01, 1993

BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMES

K931911 · Brillenerzeugung Pomberger

HQZ · Frame, Spectacle · 168d

Cleared Oct 01, 1993

FRAME - SPECTACLE

K931972 · Eyetel Optics, Inc.

HQZ · Frame, Spectacle · 162d

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