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Ophthalmic

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

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RecordFirmDate
OPTIMEDICA CATALYS PRECISION LASER SYSTEM (K113479)Optimedica Corporation2011-12-21
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (K111446)Abbott Medical Optics, Inc.2011-12-21
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES (K112302)CooperVision, Inc.2011-12-21
LIPIFLOW THERMAL PULSATION SYSTEM (K112704)Tearscience, Inc.2011-12-19
INFRASCANNER, MODEL 1000 (DEN100002)Infrascan, Inc.2011-12-13
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (K112093)Keeler Instruments, Inc.2011-12-08
EYE CARE CURE CONTACT LENS CASE (K112832)Eye Care and Cure2011-12-05
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC (K113267)CooperVision, Inc.2011-12-02
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL (K113245)CooperVision, Inc.2011-12-02
NON-CONTACT TEAR FILM THERMOGRAGH (K111771)United Integrated Services Co., Ltd.2011-11-30
FEMTEC LASER SYSTEM FOR CAPSULOTOMY (K110427)Technolas Perfect Vision GmbH2011-11-22
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE (K112425)Alcon Manufacturing, Ltd.2011-11-21
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) (K111267)Abbconcise Optical Group, LLC2011-11-08
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) (K113129)Heidelberg Engineering GmbH2011-11-08
LAMINAR FLOW PHACO TIPS (K111882)Abbott Medical Optics, Inc.2011-11-07
OPTO MITRA YELLOW LASER (K111643)Opto Electronica SA2011-11-03
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM (K103547)Lightmed Corp.2011-11-03
BIOCERAMIC ORBITAL IMPLANT, ORBTEX (K110554)Ceramisys, Ltd.2011-11-02
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS (K111345)The See Clear Company, Inc.2011-11-02
EYE-CEPT STERILE SALINE SOLUTION (K110221)Optics Laboratory, Inc.2011-11-01
EASYSCAN MODEL 1.2 (K111988)I-Optics BV2011-10-28
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (K112192)Bausch & Lomb, Inc.2011-10-25
TBD (K112098)Lensar, Inc.2011-10-19
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951)Alcon Research, Ltd.2011-10-17
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) (K101774)Alcon Manufacturing, Ltd.2011-10-13
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (K111697)Abbott Medical Optics, Inc.2011-09-27
FULL AUTO TONOMETER MODEL TX-20 (K111710)Canon Inc. -Medical Equipment Group2011-09-20
SILICONE SPHERES (K112176)Oculo Plastik, Inc.2011-09-15
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC (K111966)CooperVision, Inc.2011-09-15
DIGITAL RETINAL CAMERA (K111612)Canon, Inc.2011-09-14
RTVUE CAM WITH CORNEAL POWER UPGRADE (K111505)Optovue, Inc.2011-09-08
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI (K103132)Oculus Private Limited2011-09-08
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION (K110129)Rightmedical Products, LLC2011-08-30
P200T (K111628)Optos Plc.2011-08-19
PASCAL STREAMLINE 577 (WITH ACCESSORIES) (K111108)Topcon Medical Laser Systems, Inc.2011-08-11
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS (K110261)Soflex Limited2011-07-28
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (K111493)Nidek Co., Ltd.2011-07-27
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE (K111856)Apothecary Products, Inc.2011-07-14
RHA2020 (K111531)Annidis Health Systems Corp.2011-07-08
ASICO SOFTIP INJECTOR SYSTEM (K103495)Asico, LLC2011-06-29
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT (K110099)CooperVision, Inc.2011-06-29
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) (DEN100017)Tearscience, Inc.2011-06-28
VISTA DIGITAL OPTHALMOSCOPE (K102412)Eyequick.Llc2011-06-23
ISTAND (K103266)Optovue, Inc.2011-06-03
UNIT, PHACOFRAGMENTATION (K103023)Abbott Medical Optics, Inc.2011-06-01
SLIT LAMP SL-2G (K110489)Topcon Medical Systems, Inc.2011-05-23
CLEARCUT S SAFETY KNIFE (K110166)Alcon Research, Ltd.2011-05-20
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 (K110986)Optomed OY2011-05-16
INTEGRA LED SURGICAL HEADLIGHT SYSTEM (K110528)Integra LifeSciences Corporation2011-05-11
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (K102860)Alcon Research, Ltd.2011-05-10
ONE DAY FLAT PACK (K102895)Menicon Co, Ltd.2011-04-28
NOVAKONE SPHERICAL AND TORIC LENSES (K102557)Alden Optical Labs., Inc.2011-04-26
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, (K110452)Unilens Corp., USA2011-04-20
RETCAM 3 OPTHALMIC IMAGING SYSTEM (K102859)Clarity Medical Systems2011-04-20
ULTIMATE VIT ENHAMCER (UVE) (K102222)Medical Instrument Development Laboratories, Inc.2011-04-08
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY (K102727)Lensar, Inc.2011-03-16
ADAPT, MODEL AX-03SN (K100954)Apeliotus Vision Science, Inc.2011-02-25
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228)Nidek Incorporated2011-02-23
AAIO-7, AAIO WIRLESS (K110205)Appasamy Associates2011-02-09
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (K103561)Menicon Co, Ltd.2011-02-03
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION (K103056)Carl Zeiss Meditec, AG2011-02-01
KOWA NONMYD WX (K101628)Kowa Co. , Ltd.2011-01-26
ENDOSERTER (K090626)Ocular Systems, Inc.2011-01-21
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K102154)The Lagado Corp.2011-01-21
STERILE SALINE SOLUTION (K102165)Cachet Pharmaceuticals Pvt. , Ltd.2011-01-19
ISCREEN VISION SCREENER (K102651)Iscreen Vision, Inc.2011-01-12
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM (K101861)Truevision Systems, Incorporated2010-12-22
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE (K101782)Staar Japan2010-12-22
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (K093298)Keeler Instruments, Inc.2010-12-10
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (K093495)American Diagnostic Corp.2010-11-19
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 (K093071)Fundus Photo, LLC2010-11-17
CONSTELLATION VISION SYSTEM (K101285)Alcon Manufacturing, Ltd.2010-11-12
IOLMASTER 500 (K101182)Carl Zeiss Meditec, AG2010-11-03
DIGITAL RETINAL CAMERA (K102013)Canon Inc. -Medical Equipment Group2010-10-29
METRO SOFT (K100244)Metro Optics of Austin, Inc.2010-10-28
CVUE ADVANCED DEFINITIVE (K100456)Unilens Corp., USA2010-10-28
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL (K100443)X-Cel Contacts, Inc.2010-10-28
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM (K101935)Centervue S.P.A.2010-10-27
LENSX LASER SYSTEM (K101626)Lensx Lasers, Inc.2010-10-18
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA (K101223)Heidelberg Engineering2010-10-01
P200MAAF (K102492)Optos Plc.2010-09-30
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION (K093254)Abbott Medical Optics, Inc.2010-09-15
RTVUE MODEL RTVUE 100 (K101505)Optovue, Inc.2010-09-15
INTELLIWAVE3 (K100221)Art Optical Contact Lens, Inc.2010-09-14
STERILE SALINE SOLUTION (K093367)Cachet Pharmaceuticals Pvt. , Ltd.2010-09-10
STELLARIS PC VISION ENHANCEMENT SYSTEM (K101325)Bausch & Lomb, Inc.2010-08-17
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 (K101134)Medicel AG2010-08-09
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS (K101122)Benz Research and Development Corp.2010-08-09
MEDIWORKS SLIT LAMP (K100439)Shanghai Mediworks Precision Instruments Co. , Ltd.2010-07-16
OPTOS LIMITED PANORAMIC 200CAF (K100644)Optos Plc.2010-07-15
VISUMAX LASER KERATOME (K100253)Carl Zeiss Meditec, AG2010-07-08
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES (K091327)Alden Optical Labs., Inc.2010-06-25
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 (K100861)Optovue, Inc.2010-06-17
MAIA, MODEL 1 (K092187)Centervue S.P.A.2010-05-27
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER (K100349)Johnson & Johnson Vision Care, Inc.2010-05-21
LENSAR LASER SYSTEM (K090633)Lensar, Inc.2010-05-13
CENTRAL VISION ANALYZER MODEL 1000 (K100095)Vimetrics,Llc.2010-05-10
PASCAL STREAMLINE PHOTOCOAGULATOR (K100019)Optimedica Corporation2010-05-04
POLARIS CONTACT LENS CASE (K093377)Reliance Design & Manufacturing Corp.2010-04-27
LENSX 550 LASER SYSTEM. MODEL 550 (K094052)Lensx Lasers, Inc.2010-04-23
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