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
3776–3800 of 5119
Cleared Aug 04, 1988
OCU-FILM TIP COVER
K882750 · Oculab, Inc.
HKY · Tonometer, Manual · 30d
Cleared Aug 04, 1988
STORZ INFUSION CANNULA
K882884 · Storz Instrument Co.
HMX · Cannula, Ophthalmic · 24d
Cleared Aug 04, 1988
QRK 100, QUALITATIVE RING KERATOSCOPE
K882902 · Technitex, Inc.
HLR · Keratoscope, Battery-powered · 23d
Cleared Aug 02, 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · CooperVision, Inc.
HQF · Laser, Ophthalmic · 68d
Cleared Jul 29, 1988
BOLDREY PERIPHERAL RETINAL LENS
K882574 · Ocular Instruments, Inc.
LQJ · Lens, Surgical, Laser, Accesssory, Ophthalmic Laser · 37d
Cleared Jul 29, 1988
NEOLENS SUNGLASSES
K882813 · Neolens, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 21d
Cleared Jul 29, 1988
NEOLENS PRESCRIPTION SPECTACLE LENS
K882814 · Neolens, Inc.
HQG · Lens, Spectacle, Non-custom (prescription) · 21d
Cleared Jul 22, 1988
CR-39 PLASTIC LENSES FOR EYEGLASSES
K882308 · Automated Lens System
HQG · Lens, Spectacle, Non-custom (prescription) · 49d
Cleared Jul 15, 1988
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
K882634 · Vistech Consultants, Inc.
HOX · Chart, Visual Acuity · 18d
Cleared Jul 13, 1988
JEDMED/POLACK KERATOSCOPE HS/SL
K882618 · Gamut Ent.
HLR · Keratoscope, Battery-powered · 19d
Cleared Jul 08, 1988
COOL EYE(TM) EYE PROTECTOR
K881135 · Cool Eyes, Inc.
HOY · Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) · 114d
Cleared Jul 01, 1988
UNI-PORT
K880543 · Surgeon Surgical Instrumentation, Inc.
KYG · Device, Irrigation, Ocular Surgery · 143d
Cleared Jul 01, 1988
NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
K881635 · Noetix, Inc.
HQC · Unit, Phacofragmentation · 78d
Cleared Jul 01, 1988
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · Alcon Laboratories
KYG · Device, Irrigation, Ocular Surgery · 73d
Cleared Jul 01, 1988
SITE ULTRASONIC I/A PHACO NEEDLE
K882103 · Site Microsurgical Systems, Inc.
HQC · Unit, Phacofragmentation · 43d
Cleared Jul 01, 1988
NIDEK ARK-2000
K882191 · Nidek, Inc.
HKO · Refractometer, Ophthalmic · 38d
Cleared Jul 01, 1988
CANON AUTOREFRACTOMETER R-20
K882287 · Canon USA, Inc.
HKO · Refractometer, Ophthalmic · 30d
Cleared Jul 01, 1988
DISTOMETER
K882575 · Hagg-Streit Service, Inc.
HMM · Distometer · 9d
Cleared Jun 28, 1988
ULTRAVIOLET LIGHT PROTECTVE EYEWERE
K880666 · Free Sun Intl. AB
HOY · Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) · 131d
Cleared Jun 28, 1988
SLC HARD LENS CLEANER
K880688 · Ocular Pharmaceuticals, Inc.
LPN · Accessories, Soft Lens Products · 127d
Cleared Jun 27, 1988
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
K881358 · Neuroscientific Corp.
HOX · Chart, Visual Acuity · 88d
Cleared Jun 09, 1988
DURACLEAN DAILY CLEANER
K881987 · Allergan Optical
LPN · Accessories, Soft Lens Products · 29d
Cleared Jun 06, 1988
EFFNER CAUTERY INSTRUMENTS
K875260 · Effner and Spreine Co.
HQP · Unit, Cautery, Thermal, Battery-powered · 167d
Cleared Jun 06, 1988
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K881134 · Surgical Laser Technologies, Inc.
HQF · Laser, Ophthalmic · 82d
Cleared Jun 06, 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · Advanced Surgical Products, Inc.
HQB · Photocoagulator And Accessories · 28d

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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