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
2651–2675 of 5119
Cleared Sep 19, 1994
DISPOSABLE MICROSTAAR INJECTOR
K940593 · Staar Sugical
KYB · Lens, Guide, Intraocular · 222d
Cleared Sep 15, 1994
IOLAB LACRIMAL DUCT CATHETER
K935233 · Chiron Vision Corp.
OKS · Lacrimal Stents And Intubation Sets · 318d
Cleared Sep 14, 1994
SUNGLASSES
K940421 · Double Hero Corp.
HQY · Sunglasses (non-prescription Including Photosensitive) · 229d
Cleared Sep 14, 1994
ILO MADE IN ITALY
K943296 · Ilo Industria Lombarda Ottica Srl
HQY · Sunglasses (non-prescription Including Photosensitive) · 68d
Cleared Sep 14, 1994
SPECTACLE FRAME
K943561 · Australian Optical Co., Inc.
HQZ · Frame, Spectacle · 54d
Cleared Sep 14, 1994
SUNGLASSES
K943562 · Australian Optical Co., Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 54d
Cleared Sep 14, 1994
SUNGLASS CLIP
K943640 · Australian Optical Co., Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 49d
Cleared Sep 14, 1994
SPECTACLE FRAME
K943641 · Australian Optical Co., Inc.
HQZ · Frame, Spectacle · 49d
Cleared Sep 14, 1994
SPECTACLE FRAMES
K943792 · Kt Optique, Inc.
HQZ · Frame, Spectacle · 42d
Cleared Sep 14, 1994
NIL
K943963 · Max-Vision (H.K.)Limited
HQY · Sunglasses (non-prescription Including Photosensitive) · 30d
Cleared Sep 14, 1994
MIRAGE EYEWEAR INC.
K944026 · Mirage Eyewear, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 28d
Cleared Sep 14, 1994
NIL
K944108 · Micron Metal & Plastic Manufactory Co.
HQY · Sunglasses (non-prescription Including Photosensitive) · 22d
Cleared Sep 14, 1994
NIL
K944109 · Keep Top Intl., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 22d
Cleared Sep 08, 1994
LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS
K942494 · Permeable Technologies, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 106d
Cleared Sep 07, 1994
MAX FRAME DESIGN
K943913 · Noble Optic
HQZ · Frame, Spectacle · 27d
Cleared Sep 06, 1994
VIRECTOMY LENS
K940107 · Visionary Technologies of Miami, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 239d
Cleared Sep 06, 1994
SUNGLASSES
K942322 · Suntory Industrial Co.
HQY · Sunglasses (non-prescription Including Photosensitive) · 116d
Cleared Sep 06, 1994
SPECTACLE FRAMES
K943039 · Rodenstock USA Inc.,
HQY · Sunglasses (non-prescription Including Photosensitive) · 71d
Cleared Sep 06, 1994
SPECTACLE FRAMES
K943423 · Galilee Optics
HQZ · Frame, Spectacle · 53d
Cleared Sep 06, 1994
(BRAND NAME0 MONDAIN
K943840 · Chan'S Plastic Manufactory Co., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 32d
Cleared Sep 02, 1994
PEREGRINE WIDE ANGLE LIGHT PIPE
K940393 · Peregrine Surgical , Ltd.
HJM · Transilluminator, Ac-powered · 219d
Cleared Sep 02, 1994
SUNGLASSES
K941726 · Yowmost Enterprise Co., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 148d
Cleared Sep 02, 1994
AUTO REF-KERATOMETER, RK-3
K942242 · Cannon U.S.A., Inc.
HKO · Refractometer, Ophthalmic · 116d
Cleared Sep 02, 1994
QUADRASPHERIC FUNDUS LENS
K943125 · Volk Optical, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 65d
Cleared Sep 02, 1994
MEDPOR SURGICAL IMPLANT MATERIAL
K943275 · Porex Surgical, Inc.
HPZ · Implant, Eye Sphere · 57d

Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.

Search all Ophthalmic 510(k) devices

Filter by Product Code

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