Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 26
- Latest Decision
- 2015-04-09
Clearances · page 7 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K142056 | LIOLI IOL DELIVERY SYSTEM | Ast Products, Inc. | MSS | Class I | 2015-04-09 |
| K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | OOE | Class II | 2015-03-20 |
| K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | HOQ | Class I | 2015-03-20 |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) | Dutch Ophthalmic Research Center International BV | HQC | Class II | 2015-03-13 |
| K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | INTEROJO, Inc. | LPL | Class II | 2015-03-12 |
| K142953 | OCT-Camera | Optomedical Technologies GmbH | HLI | Class II | 2015-03-04 |
| K142172 | LIGHTMED TRUSCAN 577 | Lightmed Corp. | HQF | Class II | 2015-02-27 |
| K143431 | Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | I-Codi Co., Ltd. | LPL | Class II | 2015-02-20 |
| K133019 | FIBERION OPHTHALMIC ENDOLASER PROBE | Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim | HQF | Class II | 2015-02-20 |
| K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | Bausch & Lomb, Incorporated | LPL | Class II | 2015-02-13 |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | Heine Optotechnik GmbH & Co. KG | HLJ | Class II | 2015-01-29 |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | Alcon Laboratories, Inc. | LPN | Class II | 2015-01-26 |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | MVN | Class II | 2015-01-16 |
| K141379 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | OOE | Class II | 2015-01-16 |
| K142897 | P200DTx | Optos Plc. | MYC | Class II | 2015-01-16 |
| K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | LPL | Class II | 2015-01-12 |
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | Rayner Intraocular Lenses , Ltd. | MSS | Class I | 2014-12-18 |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and Products | Sensor Medical Technology, LLC | HJK | Class II | 2014-12-16 |
| K143052 | 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 | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2014-12-16 |
| K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Qualimed Srl | LPL | Class II | 2014-12-12 |
| K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens | Synergeyes, Inc. | HQD | Class II | 2014-11-19 |
| K141844 | RESCAN 700, CALLISTO EYE | Carl Zeiss Meditec, AG | OBO | Class II | 2014-11-18 |
| K142047 | EIDON | Centervue S.P.A. | MYC | Class II | 2014-11-12 |
| K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | Unilens Corp., USA | LPL | Class II | 2014-10-30 |
| K141325 | TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | HKI | Class II | 2014-10-23 |
| K141917 | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR | Unicon Optical Co., Ltd. | LPL | Class II | 2014-10-17 |
| K140025 | AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES | Pegavision Corporation | LPL | Class II | 2014-10-15 |
| K141954 | XCEL 455 SLIT LAMP | Reichert, Inc. | HJO | Class II | 2014-10-15 |
| K141699 | VASSEN COLOR | Vassen Co., Ltd. | LPL | Class II | 2014-10-07 |
| K142275 | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens | Neo Vision Co., Ltd. | LPL | Class II | 2014-10-07 |
| K141476 | WAVELIGHT FS200 LASER SYSTEM | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | OOE | Class II | 2014-09-30 |
| K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2014-09-18 |
| K141481 | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA | Topcon Corporation | HKI | Class II | 2014-09-17 |
| K142179 | D-KAT Z-YPE | Keeler, Ltd. | HKY | Class II | 2014-09-17 |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | HLI | Class II | 2014-09-17 |
| K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES | Katalyst Surgical, LLC | HQF | Class II | 2014-09-15 |
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | OOE | Class II | 2014-09-11 |
| K140488 | CONTACT LENS CASE | Maca Plastics, Inc. | LRX | Class II | 2014-09-10 |
| K141068 | ZEISS CATARACT SUITE MARKERLESS | Carl Zeiss Meditec, AG | HJO | Class II | 2014-09-09 |
| K133667 | SLIT LAMP SL-D701 | Topcon Corp. | HJO | Class II | 2014-08-26 |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | HQE | Class II | 2014-08-22 |
| K133562 | CATARHEX 3 | Oertli Instrumente AG | HQC | Class II | 2014-08-12 |
| K133358 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | Nidek Co., Ltd. | HQF | Class II | 2014-08-12 |
| K141280 | ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS | Seinoh Optical Co. , Ltd. | LPL | Class II | 2014-07-18 |
| K140615 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | OOE | Class II | 2014-07-15 |
| K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) | Keeler Limited | HJO | Class II | 2014-07-11 |
| K132987 | COBRA FUNDUS CAMERA | C.S.O. S.R.L. | HKI | Class II | 2014-07-03 |
| K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | Quantel Medical | HQF | Class II | 2014-06-25 |
| K133062 | DISCOVERY SYSTEM | Innovative Visual Systems | HJO | Class II | 2014-06-20 |
| K140450 | KEELER KAPTURE SOFTWARE | Keeler Limited | HKI | Class II | 2014-06-17 |
| K133403 | FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS | Firestone Optics, Inc. | LPL | Class II | 2014-06-11 |
| K133132 | OPTICAL BIOMETER AL-SCAN | Nidek Co., Ltd. | HJO | Class II | 2014-06-11 |
| K131567 | ALADDIN | Visia Imaging S.R.L. | HJO | Class II | 2014-06-05 |
| K141091 | RAYSERT PLUS INJECTOR | Rayner Intraocular Lenses , Ltd. | MSS | Class I | 2014-05-28 |
| K131711 | YZ3 PORTABLE SLIT LAMP | Suzhou 66 Vision Tech Co., Ltd. | HJO | Class II | 2014-05-09 |
| K140368 | FAMILY OF DISPOSABLE LENSES | Sensor Medical Technology, LLC | HKS | Class I | 2014-04-29 |
| K132042 | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | X6d, Ltd. | HOY | Class I | 2014-04-28 |
| K132549 | ACCUTIP COVER | Accutome, Inc. | HKY | Class II | 2014-04-23 |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | HLI | Class II | 2014-04-23 |
| K134039 | DAYTONA ICG (P200TICG) | Optos Plc. | MYC | Class II | 2014-04-11 |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR | Rayner Intraocular Lenses , Ltd. | MSS | Class I | 2014-03-27 |
| K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Amico Diagnostic Incorporated | HLI | Class II | 2014-03-26 |
| K133735 | EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2014-03-21 |
| K133892 | IVUE 500 | Optovue, Inc. | HLI | Class II | 2014-03-19 |
| K133217 | CIRRUS PHOTO | Carl Zeiss Meditec, AG | OBO | Class II | 2014-03-19 |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb | HQC | Class II | 2014-03-12 |
| K133755 | KOWA SL-17 | Kowa Co. , Ltd. | HJO | Class II | 2014-03-11 |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | HLJ | Class II | 2014-03-07 |
| K133740 | SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT | Sauflon Pharmaceuticals, Ltd. | LPL | Class II | 2014-03-05 |
| K132714 | ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) | Vision Science Co., Ltd. | LPL | Class II | 2014-03-05 |
| K133472 | SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) | Souflon Pharmaceuticals, Ltd. | LPL | Class II | 2014-03-04 |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | Abbott Medical Optics, Inc. | HQC | Class II | 2014-02-27 |
| K131783 | POLAROID CONTACTSPOD | Viopti, Ltd. | LRX | Class II | 2014-02-21 |
| K133234 | T-TYPE D-KAT, R-TYPE D-KAT | Keeler Limited | HKY | Class II | 2014-02-21 |
| K132323 | RS-3000 ADVANCE | Nidek Co., Ltd. | OBO | Class II | 2014-02-19 |
| K132534 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | OOE | Class II | 2014-02-14 |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | Bausch & Lomb | HQC | Class II | 2014-02-14 |
| K130930 | OWL CONTACT LENS CASES, DOG CONTACT LENS CASES | Ningbo Lishunda Electronics Co., Ltd. | LRX | Class II | 2014-02-12 |
| K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | Carl Zeiss Meditec, AG | HJO | Class II | 2014-02-12 |
| K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | Ciba Vision Corporation | LPL | Class II | 2014-01-29 |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | Bausch & Lomb | MSS | Class I | 2014-01-09 |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | Bausch & Lomb | MSS | Class I | 2014-01-03 |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Bausch & Lomb | MSS | Class I | 2013-12-27 |
| K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | Keeler, Ltd. | HRN | Class II | 2013-12-23 |
| K132854 | EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2013-12-23 |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | CooperVision, Inc. | LPL | Class II | 2013-12-23 |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | ORZ | Class II | 2013-12-23 |
| K132917 | OCULAR FORCE GAUGE | Ocular Therapeutix, Inc. | HKY | Class II | 2013-12-20 |
| K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | Bausch & Lomb, Incorporated | LPL | Class II | 2013-12-20 |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | Optomed OY | HKI | Class II | 2013-12-18 |
| K133079 | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) | Alden Optical Labs., Inc. | LPL | Class II | 2013-12-17 |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | HLJ | Class II | 2013-12-04 |
| K130565 | SPECULAR MICROSCOPE CEM-530 | Nidek Co., Ltd. | NQE | Class II | 2013-11-27 |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | HQB | Class II | 2013-11-14 |
| K130195 | SCANNING LASERLINK | Lumenis, Inc. | HQF | Class II | 2013-11-01 |
| K131719 | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | Medical Devices (Pvt) , Ltd. | HLJ | Class II | 2013-10-30 |
| K132796 | SUNTOUCH EYE SPEAR | Huizhou Foryou Medical Devices Co., Ltd. | HOZ | Class II | 2013-10-30 |
| K130117 | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | Network Medical Products, Ltd. | HOZ | Class II | 2013-10-29 |
| K122848 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | MSS | Class I | 2013-10-18 |
| K131207 | FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER | Surgical Instrument Engineering AG | HQF | Class II | 2013-10-09 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.