Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 28
- Latest Decision
- 2010-05-21
Clearances · page 10 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2010-05-21 |
| K090633 | LENSAR LASER SYSTEM | Lensar, Inc. | OOE | Class II | 2010-05-13 |
| K100095 | CENTRAL VISION ANALYZER MODEL 1000 | Vimetrics,Llc. | HOX | Class I | 2010-05-10 |
| K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | Optimedica Corporation | HQF | Class II | 2010-05-04 |
| K093377 | POLARIS CONTACT LENS CASE | Reliance Design & Manufacturing Corp. | LRX | Class II | 2010-04-27 |
| K094052 | LENSX 550 LASER SYSTEM. MODEL 550 | Lensx Lasers, Inc. | OOE | Class II | 2010-04-23 |
| K091404 | IVUE, MODEL 100 | Optovue, Inc. | OBO | Class II | 2010-04-22 |
| K093305 | ENHANCED ULTRA VIT PROBE | Alcon Research, Ltd. | MLZ | Class II | 2010-04-02 |
| K100202 | SLIT LAMP BO 900, BQ 900, BP900 | Haag-Streit AG | HJO | Class II | 2010-03-19 |
| K092565 | DIGITAL RETINAL CAMERA CX-1 | Canon Components, Inc. | HKI | Class II | 2010-03-18 |
| K093213 | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES | Carl Zeiss Meditec, Inc. | HPT | Class I | 2010-03-12 |
| K092852 | SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | St. shine Optical Co., Ltd. | LPL | Class II | 2010-03-11 |
| K100500 | PSL CLASSIC SLIT LAMP | Keeler Instruments, Inc. | HJO | Class II | 2010-03-09 |
| K082855 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | MRC | Class II | 2010-03-09 |
| K093210 | AQUALASE CAPSULE WASH TIP | Alcon Manufacturing, Ltd. | HQC | Class II | 2010-03-04 |
| K100207 | NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F | Topcon Corp. | HKI | Class II | 2010-02-12 |
| K093021 | ATLANTIS SLIT LAMP | Us Opthalmic, LLC | HJO | Class II | 2010-01-28 |
| K093445 | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) | Keeler, Ltd. | HKY | Class II | 2010-01-19 |
| K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | CooperVision, Inc. | LPL | Class II | 2010-01-05 |
| K091579 | FORESEE HOME | Notal Vision , Ltd. | HPT | Class I | 2009-12-23 |
| K090806 | SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON | Safilens, S.R.L. | LPL | Class II | 2009-12-18 |
| K092883 | LED LAMP OR OTHER | Intravista Medical Systems, Inc. | HJO | Class II | 2009-12-18 |
| K092647 | LENSX 550 LASER SYSTEM | Lensx Lasers, Inc. | OOE | Class II | 2009-12-11 |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 | Rayner Intraocular Lenses , Ltd. | MSS | Class I | 2009-12-04 |
| K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | Huvitz Co., Ltd. | HJO | Class II | 2009-12-03 |
| K093521 | GDXPRO | Carl Zeiss Meditec, Inc. | MYC | Class II | 2009-11-25 |
| K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | Clarity Medical Systems | HKI | Class II | 2009-11-25 |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | Bausch & Lomb, Inc. | LYL | Class II | 2009-11-18 |
| K092374 | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN | Ophthalmic Imaging Systems | HKI | Class II | 2009-11-17 |
| K091915 | FLUID ISOLATION DEVICE | Lenstec, Inc. | HQC | Class II | 2009-10-27 |
| K091064 | NAVILAS LASER SYSTEM | Od-Os GmbH | HQF | Class II | 2009-10-27 |
| K091240 | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | Alphamed, Inc. | HOZ | Class II | 2009-10-23 |
| K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | Tearscience, Inc. | HKI | Class II | 2009-10-23 |
| K091777 | ALCON ULTRACHOPPER | Alcon Research, Ltd. | HQC | Class II | 2009-10-20 |
| K082891 | LENSTAR, MODEL LS900 | Haag-Streit AG | HJO | Class II | 2009-10-20 |
| K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | Optomed OY | HKI | Class II | 2009-10-01 |
| K091981 | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER | Lightmed Corp. | HQF | Class II | 2009-09-28 |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | Topcon Medical Laser Systems, Inc. | HQF | Class II | 2009-09-25 |
| K091534 | LIGHTLAS MODEL 532 | Lightmed Corp. | HQF | Class II | 2009-09-18 |
| K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER | Innova Vision, Inc. | LPL | Class II | 2009-09-03 |
| K092470 | OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 | Topcon Corp. | OBO | Class II | 2009-09-02 |
| K083428 | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | Fiab Spa | HQP | Class II | 2009-09-01 |
| K082947 | LENSX 550 LASER SYSTEM | Lensx Lasers, Inc. | OOE | Class II | 2009-08-14 |
| K090774 | LIGHTLAS SELECTOR | Lightmed Corp. | HQF | Class II | 2009-08-13 |
| K082016 | GDX VCC WITH ECC SOFTWARE | Carl Zeiss Meditec, Inc. | MYC | Class II | 2009-08-10 |
| K091039 | KOWA, FM-600, MODEL LSS50 | Kowa Co. , Ltd. | MYC | Class II | 2009-08-07 |
| K091098 | KOWAGENESIS-DF | Kowa Co. , Ltd. | HKI | Class II | 2009-08-07 |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | Medicel AG | MSS | Class I | 2009-07-28 |
| K083377 | ACCUPEN | Accutome Ultrasound, Inc. | HKX | Class II | 2009-07-27 |
| K082871 | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM | Sis Ltd., Surgical Instrument Systems | MSS | Class I | 2009-07-09 |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | Allergan, Inc. | LPN | Class II | 2009-07-09 |
| K091683 | KOWA VX-10 A | Kowa Co. , Ltd. | HKI | Class II | 2009-07-02 |
| K090115 | RETINA CAMERA TRC-NW7SF MARK II | Topcon Corp. | HKI | Class II | 2009-06-30 |
| K082880 | EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS | I-See Vision Technology, Inc. | LPL | Class II | 2009-06-16 |
| K082196 | STATIC VESSEL ANALYZER | Imedos GmbH | HKI | Class II | 2009-06-16 |
| K091581 | SUPRA 577.Y LASER | Quantel Medical | HQF | Class II | 2009-06-16 |
| K082883 | EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR | I-See Vision Technology, Inc. | LPL | Class II | 2009-06-16 |
| K082879 | EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | I-See Vision Technology, Inc. | LPL | Class II | 2009-06-16 |
| K090161 | EPIPHANY INJECTION SYSTEM | Staar Surgical Co. | MSS | Class I | 2009-06-09 |
| K083921 | SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS | Synergeyes, Inc. | HQD | Class II | 2009-05-20 |
| K090078 | KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT | Iop, Inc. | NXM | Class II | 2009-05-08 |
| K083291 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 | Carl Zeiss Meditec, Inc. | OBO | Class II | 2009-05-05 |
| K083216 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Ciba Vision Corporation | LPL | Class II | 2009-04-14 |
| K081946 | SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR | Quantel Medical | HQF | Class II | 2009-03-25 |
| K090466 | DIGITAL RETINAL CAMERA, CR-1 MARK II | Canon, Inc. | HKI | Class II | 2009-03-23 |
| K081346 | HOYA IS INJECTOR SYSTEM | Hoya Surgical Optics, Inc. | MSS | Class I | 2009-03-23 |
| K083316 | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Topcon Medical Systems, Inc. | OBO | Class II | 2009-03-13 |
| K083342 | ORBITAL RECONSTRUCTIVE IMPLANT II | Evera Medical, Inc. | HPZ | Class II | 2009-03-12 |
| K081984 | LABORPRO SYSTEM | Trig Medical, Ltd. | NPB | Class II | 2009-03-04 |
| K090362 | IMAG, IPOD, EZ-FIND AND ISLIDE | Voguestrap | LRX | Class II | 2009-02-27 |
| K082850 | EYE SPHERES | Product and Educational Services, LLC | HPZ | Class II | 2009-02-27 |
| K082845 | INFINITI VISION SYSTEM WITH OZIL IP | Alcon Research, Ltd. | HQC | Class II | 2009-02-12 |
| K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | Clarity Medical Systems | HKI | Class II | 2009-01-30 |
| K082799 | HDS HI 1.54 | Paragon Vision Sciences | HQD | Class II | 2009-01-27 |
| K072102 | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | HNO | Class I | 2009-01-16 |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | HKI | Class II | 2009-01-16 |
| K072971 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS | Topcon Medical Systems, Inc. | OBO | Class II | 2009-01-13 |
| K082704 | BIRTHTRACK (A.K.A. CLM) | Barnev, Ltd. | NPB | Class II | 2009-01-09 |
| K082473 | BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | HQC | Class II | 2009-01-05 |
| K081877 | ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS | Dutch Ophthalmic Research Center International BV | HQC | Class II | 2009-01-05 |
| K080794 | POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Polyvue Distribution, Inc. | LPL | Class II | 2008-12-17 |
| K082460 | CENEFOM PVA SURGICAL SPEAR | Longtek Scientific Co., Ltd. | HOZ | Class II | 2008-12-15 |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | HKX | Class II | 2008-11-18 |
| K080460 | SPECTRAL OCT/SLO | Opko Health, Inc. | OBO | Class II | 2008-11-14 |
| K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM | Clarity Medical Systems | HKI | Class II | 2008-11-05 |
| K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | Duckworth & Kent, Ltd. | KYB | Class I | 2008-10-23 |
| K082767 | KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | HKI | Class II | 2008-10-21 |
| K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | Bausch & Lomb, Inc. | MSS | Class I | 2008-10-16 |
| K080632 | CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS | Clearlab SG Pte, Ltd. | MVN | Class II | 2008-10-15 |
| K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES | Contamac, Ltd. | HQD | Class II | 2008-10-09 |
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | Advanced Medical Optics, Inc. | MLZ | Class II | 2008-10-08 |
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | Advanced Medical Optics, Inc. | MSS | Class I | 2008-10-02 |
| K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | CooperVision, Inc. | LPL | Class II | 2008-09-29 |
| K081443 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | HQD | Class II | 2008-09-23 |
| K080803 | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 | American Optisurgical, Inc. | HQC | Class II | 2008-09-22 |
| K081774 | SOLX 790 TITANIUM SAPPHIRE LASER | Solx, Inc. | HQF | Class II | 2008-09-12 |
| K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Unilens Corp., USA | LPL | Class II | 2008-09-11 |
| K073508 | PARKONE | Oculus Optikgerate GmbH | MXK | Class II | 2008-09-11 |
| K080776 | GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 | Us Ophthalmic, LLC | HJO | Class II | 2008-09-09 |
| K081455 | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 | Rayner Surgical, Inc. | MSS | Class I | 2008-09-05 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.