meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
27
Latest Decision
2012-03-27

Clearances · page 9 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112977 MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) Alcon Research, Ltd. MSS Class I 2012-03-27
K112154 FEMTO LDV Sie Ag,Surgical Instument Engineering HQF Class II 2012-03-16
K112330 KOWA VX-20 Kowa Co. , Ltd. HKI Class II 2012-02-16
K111877 EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION Bausch & Lomb, Inc. LPN Class II 2012-01-24
K111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES Carl Zeiss Meditec, Inc. OBO Class II 2012-01-19
K102999 TRIMOTION INJECTOR Kaneka Corp. OTZ Class I 2011-12-29
K112302 PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES CooperVision, Inc. LPL Class II 2011-12-21
K113479 OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation OOE Class II 2011-12-21
K111446 SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM Abbott Medical Optics, Inc. HQC Class II 2011-12-21
K112704 LIPIFLOW THERMAL PULSATION SYSTEM Tearscience, Inc. ORZ Class II 2011-12-19
DEN100002 INFRASCANNER, MODEL 1000 Infrascan, Inc. OPT Class II 2011-12-13
K112093 CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER Keeler Instruments, Inc. HRN Class II 2011-12-08
K112832 EYE CARE CURE CONTACT LENS CASE Eye Care and Cure LRX Class II 2011-12-05
K113267 BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC CooperVision, Inc. LPL Class II 2011-12-02
K113245 AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL CooperVision, Inc. LPL Class II 2011-12-02
K111771 NON-CONTACT TEAR FILM THERMOGRAGH United Integrated Services Co., Ltd. HKI Class II 2011-11-30
K110427 FEMTEC LASER SYSTEM FOR CAPSULOTOMY Technolas Perfect Vision GmbH OOE Class II 2011-11-22
K112425 INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE Alcon Manufacturing, Ltd. HQC Class II 2011-11-21
K113129 SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) Heidelberg Engineering GmbH OBO Class II 2011-11-08
K111267 CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) Abbconcise Optical Group, LLC LPL Class II 2011-11-08
K111882 LAMINAR FLOW PHACO TIPS Abbott Medical Optics, Inc. HQC Class II 2011-11-07
K111643 OPTO MITRA YELLOW LASER Opto Electronica SA HQF Class II 2011-11-03
K103547 LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM Lightmed Corp. HQF Class II 2011-11-03
K111345 SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS The See Clear Company, Inc. LPL Class II 2011-11-02
K110554 BIOCERAMIC ORBITAL IMPLANT, ORBTEX Ceramisys, Ltd. HPZ Class II 2011-11-02
K110221 EYE-CEPT STERILE SALINE SOLUTION Optics Laboratory, Inc. LPN Class II 2011-11-01
K111988 EASYSCAN MODEL 1.2 I-Optics BV MYC Class II 2011-10-28
K112192 NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS Bausch & Lomb, Inc. MVN Class II 2011-10-25
K112098 TBD Lensar, Inc. OOE Class II 2011-10-19
K110951 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA Alcon Research, Ltd. HQB Class II 2011-10-17
K101774 MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) Alcon Manufacturing, Ltd. MSS Class I 2011-10-13
K111697 AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM Abbott Medical Optics, Inc. HQC Class II 2011-09-27
K111710 FULL AUTO TONOMETER MODEL TX-20 Canon Inc. -Medical Equipment Group HKX Class II 2011-09-20
K111966 PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC CooperVision, Inc. LPL Class II 2011-09-15
K112176 SILICONE SPHERES Oculo Plastik, Inc. HPZ Class II 2011-09-15
K111612 DIGITAL RETINAL CAMERA Canon, Inc. HKI Class II 2011-09-14
K111505 RTVUE CAM WITH CORNEAL POWER UPGRADE Optovue, Inc. OBO Class II 2011-09-08
K103132 FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI Oculus Private Limited LPL Class II 2011-09-08
K110129 RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION Rightmedical Products, LLC HJO Class II 2011-08-30
K111628 P200T Optos Plc. MYC Class II 2011-08-19
K111108 PASCAL STREAMLINE 577 (WITH ACCESSORIES) Topcon Medical Laser Systems, Inc. HQF Class II 2011-08-11
K110261 ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS Soflex Limited LPL Class II 2011-07-28
K111493 NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI Nidek Co., Ltd. HQB Class II 2011-07-27
K111856 SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE Apothecary Products, Inc. LRX Class II 2011-07-14
K111531 RHA2020 Annidis Health Systems Corp. HLI Class II 2011-07-08
K103495 ASICO SOFTIP INJECTOR SYSTEM Asico, LLC MSS Class I 2011-06-29
K110099 PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT CooperVision, Inc. LPL Class II 2011-06-29
DEN100017 LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) Tearscience, Inc. ORZ Class II 2011-06-28
K102412 VISTA DIGITAL OPTHALMOSCOPE Eyequick.Llc HKI Class II 2011-06-23
K103266 ISTAND Optovue, Inc. HLI Class II 2011-06-03
K103023 UNIT, PHACOFRAGMENTATION Abbott Medical Optics, Inc. HQC Class II 2011-06-01
K110489 SLIT LAMP SL-2G Topcon Medical Systems, Inc. HJO Class II 2011-05-23
K110166 CLEARCUT S SAFETY KNIFE Alcon Research, Ltd. HNN Class I 2011-05-20
K110986 OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 Optomed OY HKI Class II 2011-05-16
K110528 INTEGRA LED SURGICAL HEADLIGHT SYSTEM Integra LifeSciences Corporation FSR Class II 2011-05-11
K102860 ALCON MULTI-PIRPOSE DISINFECTING SOLUTION Alcon Research, Ltd. LPN Class II 2011-05-10
K102895 ONE DAY FLAT PACK Menicon Co, Ltd. LPL Class II 2011-04-28
K102557 NOVAKONE SPHERICAL AND TORIC LENSES Alden Optical Labs., Inc. LPL Class II 2011-04-26
K102859 RETCAM 3 OPTHALMIC IMAGING SYSTEM Clarity Medical Systems HKI Class II 2011-04-20
K110452 SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, Unilens Corp., USA LPL Class II 2011-04-20
K102222 ULTIMATE VIT ENHAMCER (UVE) Medical Instrument Development Laboratories, Inc. HQE Class II 2011-04-08
K102727 LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY Lensar, Inc. OOE Class II 2011-03-16
K100954 ADAPT, MODEL AX-03SN Apeliotus Vision Science, Inc. OUM Class I 2011-02-25
K110228 NIDEK MULTICOLOR LASER PHOTOCOAGULATOR Nidek Incorporated HQB Class II 2011-02-23
K110205 AAIO-7, AAIO WIRLESS Appasamy Associates HLI Class II 2011-02-09
K103561 MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. HQD Class II 2011-02-03
K103056 VISULAS TRION LASER SYSTEM WITH THE VITE OPTION Carl Zeiss Meditec, AG HQF Class II 2011-02-01
K101628 KOWA NONMYD WX Kowa Co. , Ltd. HKI Class II 2011-01-26
K102154 TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS The Lagado Corp. HQD Class II 2011-01-21
K090626 ENDOSERTER Ocular Systems, Inc. OTZ Class I 2011-01-21
K102165 STERILE SALINE SOLUTION Cachet Pharmaceuticals Pvt. , Ltd. LPN Class II 2011-01-19
K102651 ISCREEN VISION SCREENER Iscreen Vision, Inc. HKI Class II 2011-01-12
K101782 MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE Staar Japan MSS Class I 2010-12-22
K101861 TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM Truevision Systems, Incorporated HKI Class II 2010-12-22
K093298 PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 Keeler Instruments, Inc. HKX Class II 2010-12-10
K093495 OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS American Diagnostic Corp. HLJ Class II 2010-11-19
K093071 FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 Fundus Photo, LLC HKI Class II 2010-11-17
K101285 CONSTELLATION VISION SYSTEM Alcon Manufacturing, Ltd. HQC Class II 2010-11-12
K101182 IOLMASTER 500 Carl Zeiss Meditec, AG HJO Class II 2010-11-03
K102013 DIGITAL RETINAL CAMERA Canon Inc. -Medical Equipment Group HKI Class II 2010-10-29
K100244 METRO SOFT Metro Optics of Austin, Inc. LPL Class II 2010-10-28
K100443 DEFINITIVE, FLEXLENS - SILICONE HYDROGEL X-Cel Contacts, Inc. LPL Class II 2010-10-28
K100456 CVUE ADVANCED DEFINITIVE Unilens Corp., USA LPL Class II 2010-10-28
K101935 CENTERVUE DIGITAL RETINOGRAPHY SYSTEM Centervue S.P.A. HKI Class II 2010-10-27
K101626 LENSX LASER SYSTEM Lensx Lasers, Inc. OOE Class II 2010-10-18
K101223 SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA Heidelberg Engineering OBO Class II 2010-10-01
K102492 P200MAAF Optos Plc. MYC Class II 2010-09-30
K093254 AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION Abbott Medical Optics, Inc. LPN Class II 2010-09-15
K101505 RTVUE MODEL RTVUE 100 Optovue, Inc. HLI Class II 2010-09-15
K100221 INTELLIWAVE3 Art Optical Contact Lens, Inc. LPL Class II 2010-09-14
K093367 STERILE SALINE SOLUTION Cachet Pharmaceuticals Pvt. , Ltd. LPN Class II 2010-09-10
K101325 STELLARIS PC VISION ENHANCEMENT SYSTEM Bausch & Lomb, Inc. HQC Class II 2010-08-17
K101122 BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS Benz Research and Development Corp. LPL Class II 2010-08-09
K101134 VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 Medicel AG MSS Class I 2010-08-09
K100439 MEDIWORKS SLIT LAMP Shanghai Mediworks Precision Instruments Co. , Ltd. HJO Class II 2010-07-16
K100644 OPTOS LIMITED PANORAMIC 200CAF Optos Plc. MYC Class II 2010-07-15
K100253 VISUMAX LASER KERATOME Carl Zeiss Meditec, AG HQF Class II 2010-07-08
K091327 ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES Alden Optical Labs., Inc. LPL Class II 2010-06-25
K100861 R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 Optovue, Inc. HLI Class II 2010-06-17
K092187 MAIA, MODEL 1 Centervue S.P.A. HPT Class I 2010-05-27

4,756 clearances in the Ophthalmic panel. Data: openFDA.