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Ophthalmic

4,750 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
VANTAGE INDIRECT OPHTHALMOSCOPE (K060822)Keeler Instruments, Inc.2006-05-23
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 (K060995)Duckworth & Kent, Ltd.2006-05-22
SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES (K060821)Specialeyes, LLC2006-05-18
OPTYSE OPHTHALMOSCOPE (K061278)Ophthalmos , Ltd.2006-05-16
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS (K052290)Clearlab Pte , Ltd.2006-05-15
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES (K052832)Sauflon Pharmaceuticals, Ltd.2006-05-15
DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS (K053191)Innova Vision, Inc.2006-05-12
RS-1000 ZOOM SLITLAMP WITH OPTION (K060869)Rightmedical Products, LLC2006-05-11
ALPHASPHERE ORBITAL IMPLANT (K053298)Hydron Pty Limited2006-05-09
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM (K060533)Lenstec, Inc.2006-04-14
THE AMO OPHTHALMIC SURGICAL SYSTEM (K060366)Advanced Medical Optics, Inc.2006-04-07
TONOMETER DIATON (K060780)Ryazan State Instruments2006-04-06
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (K052891)Hawken Industries2006-03-23
EYEPORT VISION TRAINING SYSTEM (K051684)Exercise Your Eyes, Inc.2006-03-17
PANORAMIC, MODEL 200MA (K060424)Optos Plc.2006-03-17
SURGISIS OCULAR GRAFT (K053622)Iop, Inc.2006-03-15
SYNERGEYES PS HYBRID CONTACT LENS (K060102)Synergeyes, Inc.2006-03-15
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) (K051477)Mi Gwang Contact Lens Co., Ltd.2006-03-10
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (K053475)Refractec, Inc.2006-03-03
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER (K053430)Medtronic Xomed, Inc.2006-03-03
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES (K052983)Paragon Vision Sciences2006-02-10
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES (K053124)Bausch & Lomb, Incorporated2006-01-30
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 (K053176)Duckworth & Kent, Ltd.2006-01-30
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 (K053044)Opto Global, Inc.2006-01-24
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 (K052651)Rayner Surgical, Inc.2006-01-19
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) (K052935)Heidelberg Engineering2006-01-13
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS (K053425)Precision Optics Corp.2006-01-09
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS (K052606)Marietta Vision2005-12-15
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 (K050933)Medisurg , Ltd.2005-12-09
BIOFINITY (COMFILCON A) SOFT CONTACT LENS (K052560)CooperVision, Inc.2005-12-06
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS (K052675)Synergeyes2005-11-30
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL (K052703)Alden Optical Labs., Inc.2005-11-10
KOWA NONMYD 7, KOWA NONMYD A-D (K053026)Kowa Co. , Ltd.2005-11-10
KOWA GENESIS-D HAND-HELD RETINAL CAMERA (K050271)Kowa Co. , Ltd.2005-11-03
SAUFLON FLAT COLOURED LENS CASE (K052809)Sauflon Pharmaceuticals, Ltd.2005-11-02
VISUCAM PRO NM (K052268)Carl Zeiss Meditec, AG2005-11-02
TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR (K052507)The Lagado Corp.2005-11-02
KOWA VX-10 (K043213)Kowa Co. , Ltd.2005-10-06
VISANTE OCT (K051789)Carl Zeiss Meditec, Inc.2005-09-30
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES (K051944)Lumenis, Inc.2005-09-30
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA (K051940)Sis Ltd., Surgical Instrument Systems2005-09-28
REPROCESSED PHACOEMUISIFICATION TIPS (K050518)Alliance Medical, Inc.2005-09-23
20G SMA LASER FIBER, MODEL LF100 (K050807)Ophthalmed, LLC2005-09-21
ALCON MULTI-PURPOSE DISINFECTING SOLUTION (K050729)Alcon Research, Ltd.2005-09-14
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE (K041820)Ciba Vision Corporation2005-09-09
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS (K051035)Synergeyes2005-09-02
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, (K052074)Szabocsik and Associates2005-09-01
OPD-STATION SOFTWARE (K050336)Nidek, Inc.2005-08-24
MICROPULSE PHACOEMULSIFICATION SYSTEM (K051186)Trillium Medical, Inc.2005-08-18
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K051095)Optical Connection, Inc.2005-08-16
DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K051129)Innova Vision, Inc.2005-08-12
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR (K051900)Johnson & Johnson Vision Care, Inc.2005-08-12
AQUIFY MULTIPURPOSE SOLUTION (K050250)Ciba Vision Corporation2005-08-10
LENS PLUS REWETTING DROPS (K042562)Advanced Medical Optics, Inc.2005-07-29
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) (K051430)Hydrogel Vision Corporation2005-07-18
NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486)Norwood Abbey , Ltd.2005-07-06
55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K051184)United Contact Lens, Inc.2005-07-01
EYE-CEPT REWETTING DROPS (K041008)Optics Laboratory, Inc.2005-07-01
SUPER VIEW DISPOSABLE BIOM LENS SET (K051630)Insight Instruments, Inc.2005-06-29
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY (K051103)Haag-Streit USA, Inc.2005-06-07
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (K050856)Ophthocare , Ltd.2005-05-31
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES (K050638)Lenstec, Inc.2005-05-31
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES (K050065)Ciba Vision Corporation2005-05-27
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (K050948)Bausch & Lomb, Inc.2005-05-18
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC (K050717)CooperVision, Inc.2005-05-13
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY (K050541)Omniguide Communications, Inc.2005-05-09
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) (K050350)Notal Vision, Inc.2005-04-29
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS (K050157)Bausch & Lomb, Inc.2005-04-26
AQUAFLEX 2 (TEFILCON) CONTACT LENS (K050743)Unilens Corp., USA2005-04-13
JSZ-MULTIPURPOSE SOLUTION (K050517)Szabocsik and Associates2005-04-13
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (K050648)Advanced Medical Optics, Inc.2005-04-05
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 (K043503)Visx, Incorporated2005-04-05
FRESHLOOK ONE-DAY COLOR CONTACT LENS (K050213)Ciba Vision Corporation2005-03-28
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D (K050623)Volk Optical, Inc.2005-03-28
EPI-K (K043183)Moria SA2005-03-25
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II (K043613)Quantel Medical2005-03-24
THERMAL CAUTERY PROBE (K050308)Starion Instruments2005-02-25
VISCUCAM C DIGITAL CAMERA (K043222)Carl Zeiss Meditec, AG2005-02-14
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA (K043236)Quantel Medical2005-02-07
59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS (K040303)Hydrogel Vision Corporation2005-02-02
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES (K043540)Westcon Contact Lens Co., Inc.2005-02-01
AMADEUS II EPIKERATOME (K043150)Sis Ltd., Surgical Instrument Systems2005-01-31
PACHYCAM (K041841)Oculus Optikgerate GmbH2005-01-28
I-PROMOTIONS CONTACT LENS CASE (K042578)I-Promotions, Inc.2005-01-25
OCT-OPTHALMOSCOPE (K042885)Ophthalmic Technologies, Inc.2005-01-21
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) (K043129)Opti-Centre Laboratories2005-01-12
CAPSULE TENSION RING INSERTER, MODEL 7-810 (K042478)Duckworth & Kent, Ltd.2004-12-28
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) (K042099)Retinapharma Technologies, Inc.2004-12-10
STARION UNIVERSAL POWER SUPPLY (UPS) (K043155)Starion Instruments2004-12-09
TONO-PEN TONOMETER TIP COVER (K033146)Tra & Accessories2004-11-23
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K042824)CooperVision, Inc.2004-11-16
MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083)Biovision AG2004-11-16
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA (K041367)Topcon Corp.2004-11-05
AQUIFY LENS COMFORT DROPS (K042176)Ciba Vision Corporation2004-11-03
CENTURION SES EPIKERATOME (K042810)Norwood Abbey , Ltd.2004-10-28
KARATS MULTIPURPOSE SOLUTION (K031753)Ciba Vision Corporation2004-10-28
VISTAKON (SENOFILCON A) SOFT CONTACT LENS (K042275)Vistakon2004-10-28
COOPER PROSTHETIC (K042435)CooperVision, Inc.2004-10-26
COMPLETE BLINK-N-CLEAN LENS DROPS (K040839)Advanced Medical Optics, Inc.2004-10-19
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) (K042742)Heidelberg Engineering2004-10-13
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