meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
27
Latest Decision
2013-09-26

Clearances · page 8 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K124043 LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM Lightmed Corp. HQF Class II 2013-09-26
K132593 CRYSTALSERT DELIVERY SYSTEM Bausch & Lomb MSS Class I 2013-09-17
K131208 BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, Bausch & Lomb, Inc. LPL Class II 2013-09-11
K132216 BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION Bausch & Lomb, Incorporated LPN Class II 2013-09-09
K130931 EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS Jiangsu Horien Contact Lens Co., Ltd. LPL Class II 2013-08-30
K131378 SUS (STENFILCON A) CONTACT LENS CooperVision, Inc. LPL Class II 2013-08-30
K132146 SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) St. shine Optical Co., Ltd. LPL Class II 2013-08-30
K131875 MENICON NECT CONTACT LENS CASE Foresight Regulatory Strategies LRX Class II 2013-08-06
K130342 SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER Sauflon Pharmaceuticals, Ltd. LPL Class II 2013-08-05
K130933 SOLUTIS Quantel Medical HQF Class II 2013-08-02
K130331 SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER Sauflon Pharmaceuticals, Ltd. MVN Class II 2013-07-26
K130805 MENICON UNIQUE PH MULTI-PURPOSE SOLUTION Menicon Co, Ltd. MRC Class II 2013-07-03
K130656 IFUSION Optovue, Inc. HKI Class II 2013-07-03
K122202 ELLEX 2RT Ellex Medical Pty, Ltd. HQF Class II 2013-07-01
K131589 KEELER SLIT LAMP H-SERIES Keeler, Ltd. HJO Class II 2013-06-27
K122997 23GA CURVED ILLUMINATING LASER PROBE Peregrine Surgical , Ltd. HQB Class II 2013-06-26
K123431 DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D Dreamcon Co., Ltd. LPL Class II 2013-06-17
K130753 STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE Watchdog Group, LC LRX Class II 2013-06-13
K123101 TRC-50DX RETINAL CAMERA Topcon Medical Systems, Inc. HKI Class II 2013-06-05
K122700 PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES Prosben, Inc. LRX Class II 2013-05-31
K123202 PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS CooperVision, Inc. LPL Class II 2013-05-30
K123736 CRYSTALSERT DELIVERY SYSTEM Bausch & Lomb MSS Class I 2013-05-16
K123542 PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER Topcon Medical Laser Systems, Inc. HQF Class II 2013-05-15
K130734 SAUFLON MULTIPURPOSE SOLUTION Sauflon Pharmaceuticals, Ltd. LPN Class II 2013-05-15
K120756 LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE The Lagado Corp. LPL Class II 2013-05-13
K121203 BOSTON KERATOPROSTHESIS OR BOSTON KPRO Massachusetts Eye & Ear Infirmary HQM Class II 2013-05-10
K130289 TRC-NW8 NON-MYDRIATIC RETINAL CAMERA Topcon Corp. HKI Class II 2013-05-10
K122905 PEREGRINE 23GA CURVED LASER PROBE Peregrine Surgical , Ltd. HQB Class II 2013-04-30
K123973 AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES Pegavision Corporation LPL Class II 2013-04-23
K123888 Z CARTRIDGE IOL DELIVERY SYSTEM Aaren Scientific, Inc. MSS Class I 2013-04-15
K122418 IOLMASTER 500 Carl Zeiss Meditec, AG HJO Class II 2013-04-12
K130285 PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS The Lagado Corp. LRX Class II 2013-04-03
K123484 SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS St. shine Optical Co., Ltd. LPL Class II 2013-03-29
K123859 TBD Lensar, Inc. OOE Class II 2013-03-27
K123587 HEINE MINI 3000 LED OPHTHALMOSCOPE Heine Optotechnik GmbH & Co. KG HLJ Class II 2013-03-22
K122220 ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S Soflex Limited LPL Class II 2013-03-19
K123208 DIGITAL RETINAL CAMERA Canon Inc. -Medical Equipment Group HKI Class II 2013-03-19
K121622 NIDEK RS-3000 Nidek Co., Ltd. OBO Class II 2013-03-14
K123316 HEINE OMEGA 500 Heine Optotechnik GmbH & Co. KG HLI Class II 2013-02-26
K121043 OPTOS OCT/SLO MICROPERIMETER Optos Plc. OBO Class II 2013-02-22
K121738 MYVISIONTRACK(TM) Vital Art and Science Incorporated HOQ Class I 2013-02-22
K123994 DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL Ciba Vision Corporation LPL Class II 2013-02-21
K122315 FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC Oculus Private Limited LPL Class II 2013-02-15
K122386 VICTUS FEMTOSECOND LASER PLATFORM Technolas Perfect Vision GmbH OOE Class II 2013-02-08
K123460 TRC-NW300 NON-MYDRIATIC RETINAL CAMERA Topcon Medical Systems, Inc. HKI Class II 2013-02-06
K123764 DURETTE OCULAR IMPLANT Oculo-Plastik, Inc. HPZ Class II 2013-01-31
K112880 CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE Freedom Meditech, Inc. MYC Class II 2013-01-31
K121739 IVUE WITH NORMATIVE DATABASE Optovue, Inc. HLI Class II 2013-01-18
K122572 ICAM FUNDUS CAMERA Optovue, Inc. HKI Class II 2013-01-11
K120949 INFRASCANNER Infrascan, Inc. OPT Class II 2013-01-11
K122273 MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. MRC Class II 2013-01-02
K122481 LIPIVIEW OCULAR SURFACE INTERFEROMETER Tearscience, Inc. HKI Class II 2012-12-31
K121555 CENTURION VISION SYSTEM Alcon Laboratories, Inc. HQC Class II 2012-12-21
K121405 PANOPTIC Welch Allyn, Inc. HKI Class II 2012-12-20
K122575 BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI Bausch & Lomb, Inc. LPL Class II 2012-12-20
K122213 ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Soflex Limited LPL Class II 2012-12-12
K123120 LENSX LASER SYSTEM Alcon Lensx, Inc. OOE Class II 2012-12-12
K122829 LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS Lensar, Inc. HQC Class II 2012-12-03
K120904 POLARIS DIAL-A-DATE CONTACT LENS CASE Reliance Design & Manufacture Corp. LRX Class II 2012-11-26
K123056 PASCAL LASER INDIRECT OPHTHALMOSCOPE Topcon Medical Laser Systems, Inc. (Tmls) HQF Class II 2012-11-13
K113066 CORVIS ST Oculus Optikgerate GmbH HKX Class II 2012-11-08
K121201 SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS St. shine Optical Co., Ltd. LPL Class II 2012-10-26
K121993 SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT Heidelberg Engineering GmbH OBO Class II 2012-10-25
K121721 LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) Abbott Medical Optics, Inc. HQC Class II 2012-10-15
K121652 CVUE ADVANCED HYDRA VUE Unilens Corp., USA LPL Class II 2012-10-05
K121579 EK DELIVERY DEVICE Tdak Medical, Inc. OTZ Class I 2012-10-03
K120982 DIGITAL EYE-FUNDUS CAMERA Medimaging Integrated Solutions, Inc. (Miis) HKI Class II 2012-09-28
K113852 BAUSCH & LOMB IOL INJECTOR Bausch & Lomb, Inc. MSS Class I 2012-09-28
K121519 ISIGHT C&E GP Specialists, Inc. LPL Class II 2012-09-18
K121187 KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES Katalyst Surgical, LLC HQF Class II 2012-09-17
K120825 SUPRA SCAN DELIVERY SYSTEM Quantel Medical HQF Class II 2012-09-14
K120732 LENSSX LASER SYSTEM Alcon Lensx, Inc. HQC Class II 2012-09-06
K121091 CATALYS PRECISION LASER SYSTEM Optimedica Corporation OOE Class II 2012-08-28
K121324 AVT NATURASOFT Advanced Vision Technologies LPL Class II 2012-08-23
K111460 OPTO HYALUS GREEN LASER Opto Eletronica S/A HQF Class II 2012-08-20
K112373 CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION Innova Vision, Inc. LPL Class II 2012-08-17
K120426 VICTUS LASER PLATFORM Technolas Perfect Vision GmbH OOE Class II 2012-07-31
K121441 CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) Bovie Medical Corporation HQP Class II 2012-07-20
K120969 AC LENS BRANDED CONTACT LENS CASE Arlington Contact Lens Services,Inc. LRX Class II 2012-07-11
K121030 SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE Sacks Holdings, Inc. LRX Class II 2012-07-06
K120996 FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN Paragon Vision Sciences HQD Class II 2012-06-28
K121675 VERSAVIT Synergetics, Inc. HQE Class II 2012-06-21
K112184 CIRRUS PHOTO Carl Zeiss Meditec, Inc. OBO Class II 2012-06-18
K120912 INFINITI(R) VISION SYSTEM Alcon Manufacturing, Ltd. HQC Class II 2012-06-15
K120214 TBD Lensar, Inc. OOE Class II 2012-06-08
K113703 BAUSCH + LOMB NESOFILCON A CONTACT LENS Bausch & Lomb, Incorporated LPL Class II 2012-06-05
K110734 NCI SPATULA Fischer Surgical, Inc. OTZ Class I 2012-05-31
K120170 PROCARE PLUS VITRECTOMY SYSTEM Visioncare Devices, Inc. HQE Class II 2012-05-30
K120057 ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) Bioptigen, Inc. HLI Class II 2012-05-11
K112952 ILWAIT TIMER OCULOPRESSOR Oryx Medical Pty, Ltd. LCC Class II 2012-05-10
K113451 NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX Nidek Technologies Srl HKI Class II 2012-05-08
K112909 OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION Bausch & Lomb, Inc. LPN Class II 2012-04-30
K110835 GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS GEO MEDICAL CO., LTD. LPL Class II 2012-04-26
K113857 SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE Synergetics, Inc. HQB Class II 2012-04-23
K113586 SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS Synergeyes, Inc. HQD Class II 2012-04-18
K120028 AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES Pegavision Corporation LPL Class II 2012-04-17
K120264 KONAN SPECULAR MICROSCOPE XIV Konan Medical, Inc. NQE Class II 2012-04-11
K120238 RTVUE XR OCT Optovue, Inc. HLI Class II 2012-04-03
K113759 AVAIRA (ENFILCON A) CONTACT LENS CooperVision, Inc. LPL Class II 2012-04-03
K113168 DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC Ciba Vision Corporation LPL Class II 2012-03-30

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