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
4951–4975 of 5119
Cleared Mar 25, 1980
BARNES-HOND HARD CONTACT LENS STOR. CASE
K800582 · Barnes-Hind, Inc.
HPX · Lens, Contact (polymethylmethacrylate) · 11d
Cleared Mar 12, 1980
DURALITE LENS
K800192 · American Optical Corp.
HPX · Lens, Contact (polymethylmethacrylate) · 43d
Cleared Mar 12, 1980
OPHTHALMIC FORCEPS
K800368 · Edward Weck, Inc.
HNR · Forceps, Ophthalmic · 21d
Cleared Mar 12, 1980
THE LENS OR OMMI-GARD
K800521 · Gentex Corporation
HQG · Lens, Spectacle, Non-custom (prescription) · 6d
Cleared Mar 10, 1980
AMBLYOPIA TRAINER
K800112 · Life-Tech Instruments, Inc.
HPL · Device, Fixation, Ac-powered, Ophthalmic · 54d
Cleared Mar 10, 1980
MOIRE FRINGE VISOMETER AFTER LOTMAR
K800238 · Hagg-Streit Service, Inc.
HKL · Retinoscope, Ac-powered · 34d
Cleared Mar 03, 1980
CRAWFORD LACRIMAL INTUBATION SET
K800089 · Jedmed Instrument Co.
HNL · Probe, Lachrymal · 49d
Cleared Mar 03, 1980
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
K800140 · Dow Corning Corp. Healthcare Industries Materials
HQX · Implant, Orbital, Extra-ocular · 42d
Cleared Feb 19, 1980
VISALENS ALL PURPOSE SOLUTION FOR LENS
K791523 · Pfizer, Inc.
HPX · Lens, Contact (polymethylmethacrylate) · 193d
Cleared Feb 06, 1980
X-FLO
K800110 · Contemporary Surgical Systems, Inc.
HQE · Instrument, Vitreous Aspiration And Cutting, Ac-powered · 21d
Cleared Jan 29, 1980
M.P.I. LENS GLIDE
K792066 · J. Leon Bilby
KYB · Lens, Guide, Intraocular · 106d
Cleared Jan 10, 1980
SCLERAL POWDER
K791923 · Ocularists , Ltd.
HQH · Eye, Artificial, Non-custom · 106d
Cleared Dec 11, 1979
BLUE FIELD ENTOPTOSCOPE BFE100
K791510 · Medical Instrument Research Assoc., Inc.
HLI · Ophthalmoscope, Ac-powered · 131d
Cleared Dec 11, 1979
CONTACT LENSES MADE OF POLYMETHYLMETHACR
K792224 · Contact Lenses of the Pacific, Inc.
HPX · Lens, Contact (polymethylmethacrylate) · 36d
Cleared Dec 11, 1979
NEVYAS AUTOPRESS EYE COMPRESSOR
K792255 · Keeler Optical Products , Ltd.
LCC · Applicator, Ocular Pressure · 32d
Cleared Dec 11, 1979
KELMAN DIPSTICK
K792383 · V. Mueller O.V. Baxter Healthcare Corp.
HOE · Caliper, Ophthalmic · 15d
Cleared Nov 20, 1979
VISALENS CONCENTRATED CLEANER CONT LENS
K791524 · Pfizer, Inc.
HPX · Lens, Contact (polymethylmethacrylate) · 102d
Cleared Nov 16, 1979
LIO-714 OPACITYMETER
K790526 · Laser Industries , Ltd.
HJL · Lens, Condensing, Diagnostic · 246d
Cleared Nov 16, 1979
BARNES-HIND WETTING & SOAKING SOLUTION
K791901 · Barnes-Hind, Inc.
HQG · Lens, Spectacle, Non-custom (prescription) · 52d
Cleared Nov 05, 1979
(MICRO-KERATRON, MICRO DUCT TREPHINE)
K791763 · Intl. Ophthalmic Industries Corp.
HRG · Engine, Trephine, Accessories, Ac-powered · 61d
Cleared Oct 30, 1979
VERI-VU LENSOMETER
K791521 · Intermedics, Inc.
HLM · Instrument, Measuring, Lens, Ac-powered · 81d
Cleared Oct 30, 1979
OCUTOME MODEL 8000
K791898 · Cooper Medical Devices Corp.
HKP · Instrument, Vitreous Aspiration And Cutting, Battery-powered · 35d
Cleared Oct 30, 1979
X-PAK
K791917 · Contemporary Surgical Systems, Inc.
HMX · Cannula, Ophthalmic · 35d
Cleared Oct 30, 1979
REPL. PISTON FOR TROUTMAN CORNEAL PUNCH
K791988 · Edward Weck, Inc.
HNJ · Punch, Corneo-scleral · 35d
Cleared Oct 23, 1979
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · American Optical Corp.
HQG · Lens, Spectacle, Non-custom (prescription) · 54d

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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