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Ophthalmic

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

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RecordFirmDate
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) (K132146)St. shine Optical Co., Ltd.2013-08-30
MENICON NECT CONTACT LENS CASE (K131875)Foresight Regulatory Strategies2013-08-06
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (K130342)Sauflon Pharmaceuticals, Ltd.2013-08-05
SOLUTIS (K130933)Quantel Medical2013-08-02
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER (K130331)Sauflon Pharmaceuticals, Ltd.2013-07-26
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (K130805)Menicon Co, Ltd.2013-07-03
IFUSION (K130656)Optovue, Inc.2013-07-03
ELLEX 2RT (K122202)Ellex Medical Pty, Ltd.2013-07-01
KEELER SLIT LAMP H-SERIES (K131589)Keeler, Ltd.2013-06-27
23GA CURVED ILLUMINATING LASER PROBE (K122997)Peregrine Surgical , Ltd.2013-06-26
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D (K123431)Dreamcon Co., Ltd.2013-06-17
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE (K130753)Watchdog Group, LC2013-06-13
TRC-50DX RETINAL CAMERA (K123101)Topcon Medical Systems, Inc.2013-06-05
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES (K122700)Prosben, Inc.2013-05-31
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS (K123202)CooperVision, Inc.2013-05-30
CRYSTALSERT DELIVERY SYSTEM (K123736)Bausch & Lomb2013-05-16
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER (K123542)Topcon Medical Laser Systems, Inc.2013-05-15
SAUFLON MULTIPURPOSE SOLUTION (K130734)Sauflon Pharmaceuticals, Ltd.2013-05-15
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE (K120756)The Lagado Corp.2013-05-13
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA (K130289)Topcon Corp.2013-05-10
BOSTON KERATOPROSTHESIS OR BOSTON KPRO (K121203)Massachusetts Eye & Ear Infirmary2013-05-10
PEREGRINE 23GA CURVED LASER PROBE (K122905)Peregrine Surgical , Ltd.2013-04-30
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES (K123973)Pegavision Corporation2013-04-23
Z CARTRIDGE IOL DELIVERY SYSTEM (K123888)Aaren Scientific, Inc.2013-04-15
IOLMASTER 500 (K122418)Carl Zeiss Meditec, AG2013-04-12
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS (K130285)The Lagado Corp.2013-04-03
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS (K123484)St. shine Optical Co., Ltd.2013-03-29
TBD (K123859)Lensar, Inc.2013-03-27
HEINE MINI 3000 LED OPHTHALMOSCOPE (K123587)Heine Optotechnik GmbH & Co. KG2013-03-22
DIGITAL RETINAL CAMERA (K123208)Canon Inc. -Medical Equipment Group2013-03-19
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S (K122220)Soflex Limited2013-03-19
NIDEK RS-3000 (K121622)Nidek Co., Ltd.2013-03-14
HEINE OMEGA 500 (K123316)Heine Optotechnik GmbH & Co. KG2013-02-26
MYVISIONTRACK(TM) (K121738)Vital Art and Science Incorporated2013-02-22
OPTOS OCT/SLO MICROPERIMETER (K121043)Optos Plc.2013-02-22
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL (K123994)Ciba Vision Corporation2013-02-21
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC (K122315)Oculus Private Limited2013-02-15
VICTUS FEMTOSECOND LASER PLATFORM (K122386)Technolas Perfect Vision GmbH2013-02-08
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA (K123460)Topcon Medical Systems, Inc.2013-02-06
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE (K112880)Freedom Meditech, Inc.2013-01-31
DURETTE OCULAR IMPLANT (K123764)Oculo-Plastik, Inc.2013-01-31
IVUE WITH NORMATIVE DATABASE (K121739)Optovue, Inc.2013-01-18
ICAM FUNDUS CAMERA (K122572)Optovue, Inc.2013-01-11
INFRASCANNER (K120949)Infrascan, Inc.2013-01-11
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS (K122273)Menicon Co, Ltd.2013-01-02
LIPIVIEW OCULAR SURFACE INTERFEROMETER (K122481)Tearscience, Inc.2012-12-31
CENTURION VISION SYSTEM (K121555)Alcon Laboratories, Inc.2012-12-21
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575)Bausch & Lomb, Inc.2012-12-20
PANOPTIC (K121405)Welch Allyn, Inc.2012-12-20
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K122213)Soflex Limited2012-12-12
LENSX LASER SYSTEM (K123120)Alcon Lensx, Inc.2012-12-12
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS (K122829)Lensar, Inc.2012-12-03
POLARIS DIAL-A-DATE CONTACT LENS CASE (K120904)Reliance Design & Manufacture Corp.2012-11-26
PASCAL LASER INDIRECT OPHTHALMOSCOPE (K123056)Topcon Medical Laser Systems, Inc. (Tmls)2012-11-13
CORVIS ST (K113066)Oculus Optikgerate GmbH2012-11-08
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS (K121201)St. shine Optical Co., Ltd.2012-10-26
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT (K121993)Heidelberg Engineering GmbH2012-10-25
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (K121721)Abbott Medical Optics, Inc.2012-10-15
CVUE ADVANCED HYDRA VUE (K121652)Unilens Corp., USA2012-10-05
EK DELIVERY DEVICE (K121579)Tdak Medical, Inc.2012-10-03
BAUSCH & LOMB IOL INJECTOR (K113852)Bausch & Lomb, Inc.2012-09-28
DIGITAL EYE-FUNDUS CAMERA (K120982)Medimaging Integrated Solutions, Inc. (Miis)2012-09-28
ISIGHT (K121519)C&E GP Specialists, Inc.2012-09-18
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES (K121187)Katalyst Surgical, LLC2012-09-17
SUPRA SCAN DELIVERY SYSTEM (K120825)Quantel Medical2012-09-14
LENSSX LASER SYSTEM (K120732)Alcon Lensx, Inc.2012-09-06
CATALYS PRECISION LASER SYSTEM (K121091)Optimedica Corporation2012-08-28
AVT NATURASOFT (K121324)Advanced Vision Technologies2012-08-23
OPTO HYALUS GREEN LASER (K111460)Opto Eletronica S/A2012-08-20
CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION (K112373)Innova Vision, Inc.2012-08-17
VICTUS LASER PLATFORM (K120426)Technolas Perfect Vision GmbH2012-07-31
CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) (K121441)Bovie Medical Corporation2012-07-20
AC LENS BRANDED CONTACT LENS CASE (K120969)Arlington Contact Lens Services,Inc.2012-07-11
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE (K121030)Sacks Holdings, Inc.2012-07-06
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN (K120996)Paragon Vision Sciences2012-06-28
VERSAVIT (K121675)Synergetics, Inc.2012-06-21
CIRRUS PHOTO (K112184)Carl Zeiss Meditec, Inc.2012-06-18
INFINITI(R) VISION SYSTEM (K120912)Alcon Manufacturing, Ltd.2012-06-15
TBD (K120214)Lensar, Inc.2012-06-08
BAUSCH + LOMB NESOFILCON A CONTACT LENS (K113703)Bausch & Lomb, Incorporated2012-06-05
NCI SPATULA (K110734)Fischer Surgical, Inc.2012-05-31
PROCARE PLUS VITRECTOMY SYSTEM (K120170)Visioncare Devices, Inc.2012-05-30
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (K120057)Bioptigen, Inc.2012-05-11
ILWAIT TIMER OCULOPRESSOR (K112952)Oryx Medical Pty, Ltd.2012-05-10
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX (K113451)Nidek Technologies Srl2012-05-08
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909)Bausch & Lomb, Inc.2012-04-30
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K110835)GEO MEDICAL CO., LTD.2012-04-26
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (K113857)Synergetics, Inc.2012-04-23
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS (K113586)Synergeyes, Inc.2012-04-18
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES (K120028)Pegavision Corporation2012-04-17
KONAN SPECULAR MICROSCOPE XIV (K120264)Konan Medical, Inc.2012-04-11
RTVUE XR OCT (K120238)Optovue, Inc.2012-04-03
AVAIRA (ENFILCON A) CONTACT LENS (K113759)CooperVision, Inc.2012-04-03
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC (K113168)Ciba Vision Corporation2012-03-30
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977)Alcon Research, Ltd.2012-03-27
FEMTO LDV (K112154)Sie Ag,Surgical Instument Engineering2012-03-16
KOWA VX-20 (K112330)Kowa Co. , Ltd.2012-02-16
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877)Bausch & Lomb, Inc.2012-01-24
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (K111157)Carl Zeiss Meditec, Inc.2012-01-19
TRIMOTION INJECTOR (K102999)Kaneka Corp.2011-12-29
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