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Ophthalmic

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

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RecordFirmDate
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT (K073621)Art Optical Contact Lens, Inc.2008-07-03
INTEGRE PRO, MODEL L2RY (K081565)Ellex Medical Pty, Ltd.2008-07-02
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) (K072861)Acheve Technology, Inc.2008-06-24
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (K072985)Duckworth & Kent, Ltd.2008-06-20
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) (K080180)Optical Imaging , Ltd.2008-06-11
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K080755)Bausch & Lomb, Inc.2008-06-10
FALCK APPLANATION TONOMETER (FAT2) (K071755)Falck Medical, Inc.2008-06-03
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS (K081034)Synergeyes, Inc.2008-05-30
ALCON VISION SYSTEM (K063583)Alcon2008-05-09
OPHTHALMOSCOPE F-10 (K072259)Nidek Co., Ltd.2008-05-06
CR-1 (K080883)Canon, Inc.2008-04-24
WESTCON HORIZON 49% (HIOXIFILCON B) (K080686)Westcon Contact Lens Co.2008-04-22
KOWA GENESIS-D (K080681)Kowa Co. , Ltd.2008-04-04
DURETTE IMPLANT (K073293)Oculo Plastik, Inc.2008-03-19
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (K073591)Staar Surgical Co.2008-03-13
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (K073586)Staar Surgical Co.2008-03-13
STERILS SINGLE-USE I/A HANDPIECES (K073023)Bausch & Lomb, Inc.2008-03-12
INTEGRE, MODEL LP581 (K080423)Ellex Medical Pty, Ltd.2008-03-11
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR (K080193)Synergeyes, Inc.2008-03-05
VISTAKON (NARAFILCON) A SOFT CONTACT LENS (K073485)Johnson & Johnson Vision Care, Inc.2008-03-03
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES (K073459)Ciba Vision Corporation2008-02-28
SOCT COPERNICUS, MODEL 15205 (K071839)Reichert, Inc.2008-02-27
NONCON ROBO PACHY F&A (K062763)Konan Medical, Inc.2008-02-22
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS (K073184)Bausch & Lomb, Inc.2008-02-21
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K072777)Ciba Vision Corporation2008-01-24
SLIT LAMP (K073190)Huvitz Co., Ltd.2008-01-11
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (K071736)CooperVision, Inc.2008-01-04
MERILAS 532A (K072823)Meridian AG2007-12-14
ALCON MULTI-PURPOSE SOLUTION (K071236)Alcon, Inc.2007-12-12
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K073060)Innova Vision, Inc.2007-11-29
ROYALE AE 9036 LSP INJECTOR (K073010)Asico, LLC2007-11-07
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (K070270)Kirchner & Wilhelm GmbH + Co.Kg2007-11-05
NEXT GENERATION LASER (K062624)Alcon Laboratories2007-11-05
IOL INJECTOR SET (K070669)Medicel AG2007-11-01
CA, MODEL: CAM (K071250)Optovue, Inc.2007-09-28
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR (K063297)Lightmed Corp.2007-09-20
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS (K071266)Bausch & Lomb, Inc.2007-08-15
MEDPOR ATTRACTOR IMPLANT (K071335)Porex Surgical, Inc.2007-08-08
BENZ-G 4X HIOXIFILCON D (K062854)Benz Research and Development Corp.2007-08-06
TRUEFIELD ANALYZER (K063310)Seeing Machines Limited2007-08-02
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES (K071043)Bausch & Lomb, Inc.2007-08-02
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION (K070767)Lapis Lazuli International NV2007-07-24
ALLEGRO OCULYZER (K071183)Wavelight AG2007-07-20
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM (K063388)Topcon Corp.2007-06-22
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES (K071203)Optikem International, Inc.2007-06-13
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (K062541)Innova Vision, Inc.2007-06-07
ICARE TONOMETER TA01I (K063873)Tiolat OY2007-05-23
LENSTEC LC INJECTION SYSTEM (K063802)Lenstec, Inc.2007-05-07
CONTACT LENS CASE (K071081)Ningbo Kaida Rubber and Plastic Technology Co., LT2007-05-01
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES (K070637)Paragon Vision Sciences2007-05-01
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. (K070628)Contamac, Ltd.2007-05-01
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION (K062332)Altaire Pharmaceuticals, Inc.2007-04-25
ORION (K070231)Nidek Technologies Srl2007-04-24
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR (K070776)Quantel Medical2007-04-24
ORBITAL RECONSTRUCTIVE IMPLANT (K070130)Becker & Associates Consulting, Inc.2007-04-19
STARION UNIVERSAL POWER SUPPLY (K070871)Starion Instruments2007-04-13
MONARCH III IOL DELIVERY SYSTEM (K063155)Alcon Manufacturing, Ltd.2007-03-27
MODIFICATION TO: OCU-FILM TIP COVER (K070534)Reichert, Inc.2007-03-27
REPROCESSED PHACOEMULSIFICATION TIPS (K060648)Alliance Medical Corp.2007-03-19
ELLEX SLIT LAMP, MODEL 30XL (K063352)Takagi Seiko Co., Ltd.2007-03-13
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR (K070308)X-Cel Contacts2007-03-12
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (K062659)Kirwan Surgical Products, Inc.2007-03-09
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (K063694)Bausch & Lomb, Inc.2007-03-07
COMPUTERIZED LABOR MONITORING SYSTEM (DEN060006)Barnev, Ltd.2007-01-30
CIRRUS HD-OCT, MODEL 4000 (K063378)Carl Zeiss Meditec, Inc.2007-01-26
CF-1 (K063717)Canon, Inc.2007-01-23
XCEL 255 SLIT LAMP (K063750)Reichert, Inc.2006-12-20
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM (K063331)Bausch & Lomb, Inc.2006-12-19
KOWA SL-15 (K063640)Kowa Co. , Ltd.2006-12-18
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (K063343)Bioptigen, Inc.2006-12-13
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 (K062612)Rayner Surgical, Inc.2006-12-13
LUXVISION SLIT LAMP (K063416)Us Ophthalmic, LLC2006-12-07
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (K061948)CooperVision, Inc.2006-11-22
RETINAL FUNCTIONAL IMAGER (RFI) (K062416)Optical Imaging , Ltd.2006-11-17
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS (K062262)Ciba Vision Corporation2006-11-14
IRIDEX WIRELESS FOOTSWITCH (K062074)Iridex Corp2006-11-14
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K062930)Alcon Research, Ltd.2006-11-08
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A (K052599)Suzhou 66 Vision Tech Co., Ltd.2006-11-07
CRYOMATIC (K062412)Keeler Instruments, Inc.2006-11-06
KOWA VX-10I (K062021)Kowa Co. , Ltd.2006-11-01
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) (K062614)Johnson & Johnson Vision Care, Inc.2006-11-01
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES (K062548)Contamac, Ltd.2006-11-01
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT (K063191)Heidelberg Engineering2006-10-31
IRI INTEGRATED RETINAL IMAGER (K062295)Medivision Medical Imaging, Ltd.2006-10-20
RTVUE (K062552)Optovue, Inc.2006-10-06
MP-1 MICROPERIMETER (K061768)Nidek Technologies Srl2006-09-28
MOLTENO3 (K062252)Iop, Inc.2006-09-27
KOWA NONMYD ALPHA-D (K062356)Kowa Co. , Ltd.2006-09-27
AHMED GLAUCOMA VALVE, MODEL M4 (K060644)New World Medical, Inc.2006-09-18
ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465)Bausch & Lomb, Inc.2006-09-06
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER (K061674)Talia Technology , Ltd.2006-08-23
ORBITAL TISSUE EXPANDER (OTE) (K060151)Innovia, LLC2006-08-08
JSZ MULTIACTION GP CONTACT LENS SOLUTION (K060924)Szabocsik and Associates2006-06-28
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K061157)Bausch & Lomb2006-06-22
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES (K061120)Synergeyes, Inc.2006-06-22
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 (K061024)Peregrine Surgical , Ltd.2006-06-21
KOWA KT-800 (K053444)Kowa Co. , Ltd.2006-06-09
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION (K051104)Lapis Lazuli, NV2006-05-31
PSL PORTABLE SLIT LAMP (K061330)Reichert, Inc.2006-05-25
CONTACT LENS OPHTHALMODYNAMOMETER (K052674)Meditron, GmbH2006-05-24
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