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

5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2891 Ophthalmic devices
1626–1650 of 2891
Cleared Aug 26, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
K973063 · Aspect Vision Care, Ltd.
LPL · Lenses, Soft Contact, Daily Wear · 8d
Cleared Aug 25, 1997
RUFF WORK EYEGEAR
K972717 · Ruff House, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 35d
Cleared Aug 22, 1997
MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K972443 · Menicon U.S.A., Inc.
HQD · Lens, Contact (other Material) - Daily · 53d
Cleared Aug 20, 1997
OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS
K972303 · Ocular Sciences Puerto Rico, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 62d
Cleared Aug 14, 1997
CONFOSCAN
K971953 · Tomey Corporation USA
HJO · Biomicroscope, Slit-lamp, Ac-powered · 78d
Cleared Aug 08, 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K972454 · Bausch & Lomb, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 38d
Cleared Aug 06, 1997
ENDOVIEW SPPHIRE LENS SET
K971853 · American Medical Devices, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 78d
Cleared Aug 01, 1997
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
K971950 · Infinitech, Inc.
HQF · Laser, Ophthalmic · 65d
Cleared Jul 31, 1997
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
K963512 · Benz Research and Development Corp.
HQD · Lens, Contact (other Material) - Daily · 335d
Cleared Jul 31, 1997
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)
K963744 · Benz Research and Development Corp.
HQD · Lens, Contact (other Material) - Daily · 317d
Cleared Jul 31, 1997
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
K971832 · M-Pact Worldwide Management Corp.
HOZ · Sponge, Ophthalmic · 73d
Cleared Jul 31, 1997
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
K972590 · Lbi U.S.A.
HQY · Sunglasses (non-prescription Including Photosensitive) · 20d
Cleared Jul 29, 1997
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
K971671 · Heidelberg Engineering
HLI · Ophthalmoscope, Ac-powered · 83d
Cleared Jul 29, 1997
VISTA UNIVERSAL HANDPIECE
K972252 · Odyssey Technologies, Inc.
HQC · Unit, Phacofragmentation · 43d
Cleared Jul 29, 1997
P3 UNIVERSAL PHACO HANDPIECE
K972253 · Odyssey Technologies, Inc.
HQC · Unit, Phacofragmentation · 43d
Cleared Jul 25, 1997
D'ARC EYE CARE SUNGLASSES
K972490 · M & R Dist.
HQY · Sunglasses (non-prescription Including Photosensitive) · 23d
Cleared Jul 21, 1997
MOMO DESIGN OR MOMO
K972416 · Momo U.S.A., Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 24d
Cleared Jul 15, 1997
CONFOCAL MICROSCOPE
K970414 · Con-S , Ltd.
HJO · Biomicroscope, Slit-lamp, Ac-powered · 173d
Cleared Jul 15, 1997
LL BI-FOCAL, DAILY WEAR CONTACT LENS
K971647 · Lombart Lenses, Ltd.
LPL · Lenses, Soft Contact, Daily Wear · 71d
Cleared Jul 14, 1997
SUNGLASSES
K971385 · Kosway Industries Co., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 91d
Cleared Jul 14, 1997
MENTOR GEMINI HEMOSTATIC ERASER
K971538 · Mentor Ophthalmics, Inc.
HQO · Unit, Cautery, Thermal, Ac-powered · 77d
Cleared Jul 14, 1997
ALCON CONTACT LENS CASE
K971618 · Alcon Laboratories
LRX · Case, Contact Lens · 73d
Cleared Jul 14, 1997
AUTOMATED CHAMBER MAINTENANCE MODULE
K971795 · Paradigm Medical Industries, Inc.
HQC · Unit, Phacofragmentation · 60d
Cleared Jul 14, 1997
FOVS, BRILLARTE, ETC...
K972362 · Sunglass City, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 19d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970318 · Southwest Artificial Eyes, Inc.
HQN · Conformer, Ophthalmic · 160d

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 2891 LPL Lenses, Soft Contact, Daily Wear 361 HQC Unit, Phacofragmentation 196 HQF Laser, Ophthalmic 141 HQY Sunglasses (non-prescription Including Photosensitive) 124 HKI Camera, Ophthalmic, Ac-powered 111 HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered 93 LPN Accessories, Soft Lens Products 91 HQD Lens, Contact (other Material) - Daily 90 HJO Biomicroscope, Slit-lamp, Ac-powered 75 HLI Ophthalmoscope, Ac-powered 71 OBO Tomography, Optical Coherence 62 HNO Keratome, Ac-powered 59 MSS Folders And Injectors, Intraocular Lens (iol) 50 HMX Cannula, Ophthalmic 49 NFJ System, Image Management, Ophthalmic 49