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

5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1303 Ophthalmic devices
626–650 of 1303
Cleared Mar 26, 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · Ciba Vision Corporation
LPN · Accessories, Soft Lens Products · 152d
Cleared Mar 23, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
K010636 · Ciba Vision Corporation
MVN · Lens, Contact, (disposable) · 18d
Cleared Mar 08, 2001
FOCUS DAILIES PROGRESSIVES
K003826 · Ciba Vision Corporation
MVN · Lens, Contact, (disposable) · 87d
Cleared Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376 · Welch Allyn, Inc.
HLI · Ophthalmoscope, Ac-powered · 87d
Cleared Dec 13, 2000
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K003071 · Ciba Vision Corporation
LPL · Lenses, Soft Contact, Daily Wear · 72d
Cleared Dec 11, 2000
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc.
HKX · Tonometer, Ac-powered · 126d
Cleared Oct 17, 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc.
LPN · Accessories, Soft Lens Products · 36d
Cleared Sep 13, 2000
METHAFILCON A
K002625 · CooperVision, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 21d
Cleared Jul 31, 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc.
LPN · Accessories, Soft Lens Products · 75d
Cleared Jun 21, 2000
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606 · Canon USA, Inc.
HLI · Ophthalmoscope, Ac-powered · 323d
Cleared May 19, 2000
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
K000637 · Alcon Laboratories, Inc.
NCF · Aberrometer, Ophthalmic · 84d
Cleared May 19, 2000
POLYMACON
K001089 · CooperVision, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 45d
Cleared May 19, 2000
METHAFILCON A
K001090 · CooperVision, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 45d
Cleared May 15, 2000
SOLO-CARE BRAND HARD SOLUTION
K000607 · Ciba Vision Corporation
MRC · Products, Contact Lens Care, Rigid Gas Permeable · 82d
Cleared Apr 20, 2000
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · Bausch & Lomb, Inc.
LPN · Accessories, Soft Lens Products · 84d
Cleared Apr 11, 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · Alcon Laboratories
MRC · Products, Contact Lens Care, Rigid Gas Permeable · 84d
Cleared Mar 20, 2000
IOLMASTER
K993357 · Carl Zeiss, Inc.
HJO · Biomicroscope, Slit-lamp, Ac-powered · 166d
Cleared Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · CooperVision, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 28d
Cleared Mar 03, 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
K994125 · Bausch & Lomb, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 87d
Cleared Jan 07, 2000
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
K993039 · Bausch & Lomb, Inc.
MRH · Pump, Infusion, Ophthalmic · 119d
Cleared Jan 05, 2000
SOLO-CARE BRAND HARD SOLUTION
K993949 · Ciba Vision Corporation
MRC · Products, Contact Lens Care, Rigid Gas Permeable · 44d
Cleared Dec 21, 1999
KEELER CRYO MASTER & PROBES
K992954 · Keeler Instruments, Inc.
HRN · Unit, Cryophthalmic, Ac-powered · 111d
Cleared Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
K993252 · CooperVision, Inc.
MVN · Lens, Contact, (disposable) · 57d
Cleared Nov 02, 1999
KSEA DE LA PLAZA BLEPHAROPLASTY SET
K991592 · KARL STORZ Endoscopy-America, Inc.
HNI · Retractor, Ophthalmic · 179d
Cleared Sep 24, 1999
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc.
HNO · Keratome, Ac-powered · 190d

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All categories 1303 LPL Lenses, Soft Contact, Daily Wear 161 HQC Unit, Phacofragmentation 81 HQF Laser, Ophthalmic 64 HKI Camera, Ophthalmic, Ac-powered 59 LPN Accessories, Soft Lens Products 52 HMX Cannula, Ophthalmic 37 OBO Tomography, Optical Coherence 37 HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered 37 NFJ System, Image Management, Ophthalmic 34 HNR Forceps, Ophthalmic 28 HJK Lens, Contact, Polymethylmethacrylate, Diagnostic 28 HQD Lens, Contact (other Material) - Daily 26 HJO Biomicroscope, Slit-lamp, Ac-powered 25 HKX Tonometer, Ac-powered 23 HNN Knife, Ophthalmic 21