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
5101–5119 of 5119
Cleared Oct 21, 1976
CASE, CONTACT LENS, PLASTIC
K760046 · Tomlin B. Horsley, Jr.
HPX · Lens, Contact (polymethylmethacrylate) · 128d
Cleared Oct 20, 1976
NALGENE EMERGENCY EYE WASH
K760820 · Nagle Co.
KYG · Device, Irrigation, Ocular Surgery · 7d
Cleared Oct 15, 1976
SOLA COMMIDO LOUPE
K760770 · Codman & Shurtleff, Inc.
HLJ · Ophthalmoscope, Battery-powered · 11d
Cleared Oct 15, 1976
SOLA SCHULTZE-CROCK OPTHALMOSCOPE
K760771 · Codman & Shurtleff, Inc.
HLJ · Ophthalmoscope, Battery-powered · 11d
Cleared Oct 05, 1976
IMPLANT, SILICONE AND TANTALUM
K760550 · Medical Instrument Research Assoc., Inc.
HQJ · Implant, Absorbable, (scleral Buckling Methods) · 36d
Cleared Oct 05, 1976
VISC X-VITREOUS ASPIRATING & CUT. INSTR
K760684 · Varian Assoc., Inc.
HKP · Instrument, Vitreous Aspiration And Cutting, Battery-powered · 15d
Cleared Oct 05, 1976
ELECTRO-KERATOTOME, LINE-OPERATED
K760726 · Storz Instrument Co.
HNO · Keratome, Ac-powered · 8d
Cleared Aug 26, 1976
PHOTOCOAGULATOR, LOG 3 PORTABLE XENON
K760444 · Varian Assoc., Inc.
HQB · Photocoagulator And Accessories · 10d
Cleared Aug 09, 1976
LENSES, CONTACT, POLYMETHYL METHACRYLATE
K760213 · Progressive Affiliated Labs, Inc.
HPX · Lens, Contact (polymethylmethacrylate) · 28d
Cleared Aug 04, 1976
SCISSORS, MICRO IRIS STRAIGHT
K760185 · V. Mueller O.V. Baxter Healthcare Corp.
HNF · Scissors, Ophthalmic · 29d
Cleared Aug 04, 1976
DISSECTOR, TROUTMAN CORNEAL
K760186 · V. Mueller O.V. Baxter Healthcare Corp.
HNN · Knife, Ophthalmic · 29d
Cleared Aug 04, 1976
KNIFE, TROUTMAN CORNEAL SMALL
K760187 · V. Mueller O.V. Baxter Healthcare Corp.
HNN · Knife, Ophthalmic · 29d
Cleared Aug 04, 1976
SCISSORS, MICRO IRIS CURVED
K760188 · V. Mueller O.V. Baxter Healthcare Corp.
HNF · Scissors, Ophthalmic · 29d
Cleared Aug 04, 1976
SCISSORS, IRIS STRAIGHT
K760190 · V. Mueller O.V. Baxter Healthcare Corp.
HNF · Scissors, Ophthalmic · 29d
Cleared Aug 04, 1976
KNIFE, TROUTMAN CORNEAL LARGE
K760191 · V. Mueller O.V. Baxter Healthcare Corp.
HNN · Knife, Ophthalmic · 29d
Cleared Aug 04, 1976
ELECTRORETINOGRAPH
K760199 · Lkc Technologies, Inc.
HLZ · Electrode, Corneal · 28d
Cleared Aug 04, 1976
BUTTONS, PMMA (FOR CONTACT LENSES)
K760204 · Burton Parsons & Co., Inc.
HPX · Lens, Contact (polymethylmethacrylate) · 27d
Cleared Aug 04, 1976
SURGICAL INSTRUMENTS, OPTHALMIC
K760326 · Depuy, Inc.
HNF · Scissors, Ophthalmic · 9d
Cleared Jul 20, 1976
LENS, HARD CONTACT
K760126 · Tru-Form Optics, Inc.
HPX · Lens, Contact (polymethylmethacrylate) · 22d

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