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Ophthalmic

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

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RecordFirmDate
LIGHTMED TRUSCAN 577 (K142172)Lightmed Corp.2015-02-27
FIBERION OPHTHALMIC ENDOLASER PROBE (K133019)Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim2015-02-20
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (K143431)I-Codi Co., Ltd.2015-02-20
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens (K143632)Bausch & Lomb, Incorporated2015-02-13
HEINE SIGMA 250 & HEINE SIGMA 250 M2 (K142837)Heine Optotechnik GmbH & Co. KG2015-01-29
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE (K142284)Alcon Laboratories, Inc.2015-01-26
P200DTx (K142897)Optos Plc.2015-01-16
VICTUS FEMTOSECOND LASER PLATFORM (K141379)Technolas Perfect Vision GmbH2015-01-16
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (K143190)Yung Sheng Optical Co., Ltd.2015-01-16
Intelliwave4 (K142641)Art Optical Contact Lens, Inc.2015-01-12
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (K143307)Rayner Intraocular Lenses , Ltd.2014-12-18
Sensor Medical Family of Vitrectomy Lenses and Products (K142715)Sensor Medical Technology, LLC2014-12-16
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens (K143052)Yung Sheng Optical Co., Ltd.2014-12-16
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (K142384)Qualimed Srl2014-12-12
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens (K142510)Synergeyes, Inc.2014-11-19
RESCAN 700, CALLISTO EYE (K141844)Carl Zeiss Meditec, AG2014-11-18
EIDON (K142047)Centervue S.P.A.2014-11-12
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens (K142851)Unilens Corp., USA2014-10-30
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA (K141325)Topcon Corp.2014-10-23
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR (K141917)Unicon Optical Co., Ltd.2014-10-17
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES (K140025)Pegavision Corporation2014-10-15
XCEL 455 SLIT LAMP (K141954)Reichert, Inc.2014-10-15
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens (K142275)Neo Vision Co., Ltd.2014-10-07
VASSEN COLOR (K141699)Vassen Co., Ltd.2014-10-07
WAVELIGHT FS200 LASER SYSTEM (K141476)Alcon Research, Ltd. Dba Alcon Laboratories, Inc.2014-09-30
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA (K141670)Johnson & Johnson Vision Care, Inc.2014-09-18
D-KAT Z-YPE (K142179)Keeler, Ltd.2014-09-17
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (K141638)Propper Manufacturing Co., Inc.2014-09-17
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA (K141481)Topcon Corporation2014-09-17
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES (K140362)Katalyst Surgical, LLC2014-09-15
OPTIMEDICA CATALYS PRECISION LASER SYSTEM (K141079)Optimedica Corporation2014-09-11
CONTACT LENS CASE (K140488)Maca Plastics, Inc.2014-09-10
ZEISS CATARACT SUITE MARKERLESS (K141068)Carl Zeiss Meditec, AG2014-09-09
SLIT LAMP SL-D701 (K133667)Topcon Corp.2014-08-26
CONSTELLATION VISION SYSTEM (K141065)Alcon Research, Ltd.2014-08-22
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K133358)Nidek Co., Ltd.2014-08-12
CATARHEX 3 (K133562)Oertli Instrumente AG2014-08-12
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS (K141280)Seinoh Optical Co. , Ltd.2014-07-18
VICTUS FEMTOSECOND LASER PLATFORM (K140615)Technolas Perfect Vision GmbH2014-07-15
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) (K140451)Keeler Limited2014-07-11
COBRA FUNDUS CAMERA (K132987)C.S.O. S.R.L.2014-07-03
OPTIMUS FUSION: SLT, YAG AND YAG/SLT (K140336)Quantel Medical2014-06-25
DISCOVERY SYSTEM (K133062)Innovative Visual Systems2014-06-20
KEELER KAPTURE SOFTWARE (K140450)Keeler Limited2014-06-17
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS (K133403)Firestone Optics, Inc.2014-06-11
OPTICAL BIOMETER AL-SCAN (K133132)Nidek Co., Ltd.2014-06-11
ALADDIN (K131567)Visia Imaging S.R.L.2014-06-05
RAYSERT PLUS INJECTOR (K141091)Rayner Intraocular Lenses , Ltd.2014-05-28
YZ3 PORTABLE SLIT LAMP (K131711)Suzhou 66 Vision Tech Co., Ltd.2014-05-09
FAMILY OF DISPOSABLE LENSES (K140368)Sensor Medical Technology, LLC2014-04-29
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (K132042)X6d, Ltd.2014-04-28
CENTERVUE MACULAR INTEGRITY ASSESSMENT (K133758)Centervue S.P.A.2014-04-23
ACCUTIP COVER (K132549)Accutome, Inc.2014-04-23
DAYTONA ICG (P200TICG) (K134039)Optos Plc.2014-04-11
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR (K132002)Rayner Intraocular Lenses , Ltd.2014-03-27
AMICO DH-W35 OPHTHALMOSCOPE SERIES (K131939)Amico Diagnostic Incorporated2014-03-26
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (K133735)Yung Sheng Optical Co., Ltd.2014-03-21
CIRRUS PHOTO (K133217)Carl Zeiss Meditec, AG2014-03-19
IVUE 500 (K133892)Optovue, Inc.2014-03-19
STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486)Bausch & Lomb2014-03-12
KOWA SL-17 (K133755)Kowa Co. , Ltd.2014-03-11
HEINE MINI 3000(R) OPHTHALMOSCOPE (K131959)Heine Optotechnik GmbH & Co. KG2014-03-07
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) (K132714)Vision Science Co., Ltd.2014-03-05
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT (K133740)Sauflon Pharmaceuticals, Ltd.2014-03-05
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) (K133472)Souflon Pharmaceuticals, Ltd.2014-03-04
COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK (K133115)Abbott Medical Optics, Inc.2014-02-27
POLAROID CONTACTSPOD (K131783)Viopti, Ltd.2014-02-21
T-TYPE D-KAT, R-TYPE D-KAT (K133234)Keeler Limited2014-02-21
RS-3000 ADVANCE (K132323)Nidek Co., Ltd.2014-02-19
STELLARIS VISION ENHANCEMENT SYSTEM (K133242)Bausch & Lomb2014-02-14
VICTUS FEMTOSECOND LASER PLATFORM (K132534)Technolas Perfect Vision GmbH2014-02-14
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES (K130930)Ningbo Lishunda Electronics Co., Ltd.2014-02-12
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION (K133476)Carl Zeiss Meditec, AG2014-02-12
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL (K133176)Ciba Vision Corporation2014-01-29
BAUSCH & LOMB INJECTOR SYSTEM (K131958)Bausch & Lomb2014-01-09
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146)Bausch & Lomb2014-01-03
EASY-LOAD LENS DELIVERY SYSTEM (K132481)Bausch & Lomb2013-12-27
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K132854)Yung Sheng Optical Co., Ltd.2013-12-23
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS (K133627)CooperVision, Inc.2013-12-23
LIPIFLOW THERMAL PULSATION SYSTEM (K133127)Tearscience, Inc.2013-12-23
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (K131787)Keeler, Ltd.2013-12-23
OCULAR FORCE GAUGE (K132917)Ocular Therapeutix, Inc.2013-12-20
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS (K132715)Bausch & Lomb, Incorporated2013-12-20
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 (K132186)Optomed OY2013-12-18
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) (K133079)Alden Optical Labs., Inc.2013-12-17
HEINE BETA 200(R) OPHTHALMOSCOPE (K131961)Heine Optotechnik GmbH & Co. KG2013-12-04
SPECULAR MICROSCOPE CEM-530 (K130565)Nidek Co., Ltd.2013-11-27
PEREGRINE CURVED ILLUMINATING LASER PROBE (K132614)Peregrine Surgical , Ltd.2013-11-14
SCANNING LASERLINK (K130195)Lumenis, Inc.2013-11-01
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (K131719)Medical Devices (Pvt) , Ltd.2013-10-30
SUNTOUCH EYE SPEAR (K132796)Huizhou Foryou Medical Devices Co., Ltd.2013-10-30
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (K130117)Network Medical Products, Ltd.2013-10-29
LENSTEC LC INJECTION SYSTEM (K122848)Lenstec, Inc.2013-10-18
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER (K131207)Surgical Instrument Engineering AG2013-10-09
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM (K124043)Lightmed Corp.2013-09-26
CRYSTALSERT DELIVERY SYSTEM (K132593)Bausch & Lomb2013-09-17
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208)Bausch & Lomb, Inc.2013-09-11
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION (K132216)Bausch & Lomb, Incorporated2013-09-09
SUS (STENFILCON A) CONTACT LENS (K131378)CooperVision, Inc.2013-08-30
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS (K130931)Jiangsu Horien Contact Lens Co., Ltd.2013-08-30
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