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
2751–2775 of 5119
Cleared Jul 25, 1994
SUNGLASSES
K942037 · Golden Year Supply Co.
HQY · Sunglasses (non-prescription Including Photosensitive) · 88d
Cleared Jul 25, 1994
SUNGLASSES
K942038 · Golden Year Supply Co.
HQY · Sunglasses (non-prescription Including Photosensitive) · 88d
Cleared Jul 25, 1994
SAM SUNG OPTICAL
K942067 · Sam Sung Optical
HQY · Sunglasses (non-prescription Including Photosensitive) · 87d
Cleared Jul 25, 1994
PHACO KIT
K942515 · Surgin Surgical Instrumentation, Inc.
HQC · Unit, Phacofragmentation · 60d
Cleared Jul 25, 1994
10-0 CASSETTE
K942516 · Surgin Surgical Instrumentation, Inc.
HQC · Unit, Phacofragmentation · 60d
Cleared Jul 25, 1994
10-K CASSETTE
K942517 · Surgin Surgical Instrumentation, Inc.
HQC · Unit, Phacofragmentation · 60d
Cleared Jul 25, 1994
CASSETTE SYSTEM FOR SITE
K942518 · Surgin Surgical Instrumentation, Inc.
HQC · Unit, Phacofragmentation · 60d
Cleared Jul 25, 1994
NON-PRESCRIPTION SUNGLASSES
K942673 · Angel Eyewear
HQY · Sunglasses (non-prescription Including Photosensitive) · 49d
Cleared Jul 25, 1994
SPECTACLE FRAMES
K942750 · Aspex Eyewear, Inc.
HQZ · Frame, Spectacle · 45d
Cleared Jul 25, 1994
NIL
K942755 · Ever Great International , Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 45d
Cleared Jul 25, 1994
ORVIS WORLD FINEST POLARIZED CLIP ONS
K942952 · The Orvis Co., Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 32d
Cleared Jul 25, 1994
SPECTACLE FRAME
K943084 · Samil Enterprise Co.
HQZ · Frame, Spectacle · 27d
Cleared Jul 19, 1994
MICRON-SCOPE II
K926412 · Chiron Vision Corp.
HMS · Drum, Eye Knife Test · 575d
Cleared Jul 18, 1994
OPHTHALMIC CRYO UNIT
K940373 · Dutch Ophthalmic USA, Inc.
HPS · Unit, Cryophthalmic · 173d
Cleared Jul 18, 1994
NERVE FIBER ANALYZER
K941705 · Carl Zeiss Meditec, Inc.
HLI · Ophthalmoscope, Ac-powered · 103d
Cleared Jul 15, 1994
NON-PRESCRIPTION SUNGLASSES
K936072 · King'S Sunglass Corp.
HQY · Sunglasses (non-prescription Including Photosensitive) · 207d
Cleared Jul 15, 1994
NIDEK MODEL VT-4000, MODIFICATION
K936302 · Nidek, Inc.
HQE · Instrument, Vitreous Aspiration And Cutting, Ac-powered · 198d
Cleared Jul 15, 1994
RETURN PATH DIATHERMY HANDLE
K941495 · Mira, Inc.
HQR · Apparatus, Cautery, Radiofrequency, Ac-powered · 109d
Cleared Jul 15, 1994
U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES
K942119 · U-Top Enterprise Co., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 73d
Cleared Jul 15, 1994
SEIKO EYEGLASS FRAME
K942513 · Seiko Optical Products of America, Inc.
HQZ · Frame, Spectacle · 50d
Cleared Jul 15, 1994
SURGI-WIPE
K942642 · Surgin Surgical Instrumentation, Inc.
HOZ · Sponge, Ophthalmic · 42d
Cleared Jul 15, 1994
NON-PRESCRIPTION SUNGLASSES
K942783 · Sunpoint Import Co., Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 31d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES
K925596 · European & Foreign Imports, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 614d
Cleared Jul 12, 1994
CHEN-HERSIN SUNGLASSES
K940488 · Chen Hersin Ent.
HQY · Sunglasses (non-prescription Including Photosensitive) · 158d
Cleared Jul 12, 1994
AUTO REFF-30
K940516 · Canon, Inc.
HKO · Refractometer, Ophthalmic · 158d

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All categories 5119 HQY Sunglasses (non-prescription Including Photosensitive) 646 LPL Lenses, Soft Contact, Daily Wear 490 HQC Unit, Phacofragmentation 317 HQZ Frame, Spectacle 198 HQF Laser, Ophthalmic 179 HKI Camera, Ophthalmic, Ac-powered 156 HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered 148 LPN Accessories, Soft Lens Products 121 HQD Lens, Contact (other Material) - Daily 118 HJO Biomicroscope, Slit-lamp, Ac-powered 108 HLI Ophthalmoscope, Ac-powered 85 HNO Keratome, Ac-powered 83 LRX Case, Contact Lens 82 HMX Cannula, Ophthalmic 77 HPX Lens, Contact (polymethylmethacrylate) 74