Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 34
- Latest Decision
- 2002-03-11
Clearances · page 15 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K014000 | VISTITOME 20-10 MICROKERATOME | Biovision AG | HNO | Class I | 2002-03-11 |
| K014044 | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) | Notal Vision, Inc. | HOQ | Class I | 2002-03-04 |
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | Ocular Instruments, Inc. | HJK | Class II | 2002-03-04 |
| K020193 | OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Cl Mcintosh | LPL | Class II | 2002-02-28 |
| K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | Vistakon | LPL | Class II | 2002-02-26 |
| K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | LPN | Class II | 2002-02-20 |
| K013259 | PORTABLE NON-CONTACT TONOMETER, MODEL PT100 | Leica Microsystems, Inc. O.I.D. | HKX | Class II | 2002-02-20 |
| K011833 | MB 103 MILLENNIUM BLADES | Millennium Biomedical, Inc. | HNO | Class I | 2002-02-15 |
| K020122 | MB 102 MILLENNIUM BLADES | Millennium Biomedical, Inc. | HNO | Class I | 2002-02-15 |
| K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR | Nidek, Inc. | HQF | Class II | 2002-02-11 |
| K013479 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | LPN | Class II | 2002-02-11 |
| K014162 | MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND | Lobob Laboratories, Inc. | MRC | Class II | 2002-01-15 |
| K013649 | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS | Sauflon Pharmaceuticals, Ltd. | LPL | Class II | 2001-12-26 |
| K013445 | OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES | Florida Optical Engineering, Inc. | LPL | Class II | 2001-12-26 |
| K012731 | SOLO-CARE PLUS MULTIPURPOSE SOLUTION | Ciba Vision Corporation | LPN | Class II | 2001-12-26 |
| K013377 | BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Ocular Sciences Puerto Rico, Inc. | LPL | Class II | 2001-12-20 |
| K013512 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | LPN | Class II | 2001-12-20 |
| K010559 | SAUFLON MULTI LENS CARE SYSTEM | Sauflon Pharmaceuticals, Ltd. | LPN | Class II | 2001-12-20 |
| K013110 | ANISEIKONIA INSPECTOR | Optical Diagnostics, Inc. | HJT | Class I | 2001-12-19 |
| K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM | Bkg Opthalmics USA, Inc. | HRG | Class I | 2001-12-14 |
| K013337 | PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI | Surgin, Inc. | HNO | Class I | 2001-12-13 |
| K011893 | COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES | Contact Color Srl | LPL | Class II | 2001-12-06 |
| K013469 | EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Soflex Contact Lens Industries , Ltd. | LPL | Class II | 2001-11-20 |
| K011561 | SEREINE EXTRA STRENGTH DAILY CLEANER | Wilsa, Inc. | LPN | Class II | 2001-11-20 |
| K013232 | CYBERCASES BY BAUSCH & LOMB | Bausch & Lomb, Inc. | LRX | Class II | 2001-11-20 |
| K013467 | TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Soflex Contact Lens Industries , Ltd. | LPL | Class II | 2001-11-20 |
| K013220 | HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) | Poly Vue Technolgies, Inc. | LPL | Class II | 2001-11-20 |
| K012873 | DOCUMENTING LASER SLIT LAMP, DP 2010 | Bausch & Lomb, Inc. | HJO | Class II | 2001-11-19 |
| K012698 | VANGUARD REPROCESSED PHACOEMULSIFICATION | Vanguard Medical Concepts, Inc. | NKX | Class II | 2001-11-09 |
| K012579 | REPROCESSED PHACO TIPS | Sterilmed, Inc. | NKX | Class II | 2001-11-08 |
| K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB | Surgin Surgical Instrumentation, Inc. | HNO | Class I | 2001-11-06 |
| K011796 | RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | LPN | Class II | 2001-11-01 |
| K012416 | CONFOSCAN 2 CONFOCAL MICROSCOPE | Nidek Technologies Srl | HJO | Class II | 2001-10-26 |
| K011392 | MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER | Micra Instruments | MSS | Class I | 2001-10-22 |
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | Dutch Ophthalmic USA, Inc. | HRN | Class II | 2001-10-22 |
| K012425 | BIOMEDICS UV MULTIFOCAL | Ocular Sciences Puerto Rico, Inc. | LPL | Class II | 2001-10-12 |
| K012435 | ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 | Bausch & Lomb, Inc. | NGY | Class I | 2001-10-02 |
| K011877 | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM | Carl Zeiss Jena GmbH | HKI | Class II | 2001-09-26 |
| K012298 | THE INTUITIVE COLORIMETER | Cerium Optical Technologies, Inc. | NFD | Class I | 2001-09-26 |
| K011945 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION | Polymer Technology Corp. | HQD | Class II | 2001-09-12 |
| K012530 | AA-1 SYSTEM | Neurovision, Inc. | HJT | Class I | 2001-08-31 |
| K012196 | ULTRACELL ABSORBENT STICK | Ultracell Medical Technologies, Inc. | HOZ | Class II | 2001-08-24 |
| K011072 | GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS | Gelflex | LPL | Class II | 2001-08-24 |
| K012096 | DISPOSABLE VITRECTOMY LENS | Ocular Instruments, Inc. | HJK | Class II | 2001-08-24 |
| K010372 | LIGHTLAS 532 PHOTOCOAGULATOR | Lightmed Corp. | HQF | Class II | 2001-08-22 |
| K010852 | OSMED TISSUE EXPANDER | Iop, Inc. | NFM | Class II | 2001-08-13 |
| K010454 | THE ALBERTA LENS SM2, SULFOCON B | Progressive Optical Research , Ltd. | HQD | Class II | 2001-08-01 |
| K011914 | HYDRO2, HS-75 | Innovision, Inc. | HQD | Class II | 2001-07-27 |
| K011718 | BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT | Bausch & Lomb, Inc. | MVN | Class II | 2001-07-25 |
| K011256 | TORIC LITE LENS | Soflex Contact Lens Industries , Ltd. | LPL | Class II | 2001-07-17 |
| K011456 | DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | MRC | Class II | 2001-07-17 |
| K011498 | EASY CONTROL MICRO INSERTER, MODEL ON385 | Ophtec USA, Inc. | NCE | Class I | 2001-07-09 |
| K002099 | S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- | Bescon Co., Ltd. | LPL | Class II | 2001-07-09 |
| K001962 | S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- | Bescon Co., Ltd. | LPL | Class II | 2001-07-09 |
| K011199 | PROVIEW EYE PRESSURE MONITOR | Bausch & Lomb, Inc. | HKY | Class II | 2001-07-02 |
| K011740 | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | Meddev Corp. | MML | Class II | 2001-07-02 |
| K010998 | LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 | Langham Ophthalmic Technologies | HKX | Class II | 2001-06-27 |
| K011191 | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES | Medtronic Xomed, Inc. | HOZ | Class II | 2001-06-26 |
| K011542 | SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) | Specialty Ultravision, Inc. | LPL | Class II | 2001-06-26 |
| K010872 | ML BLADE, MODEL ML7030 | Med-Logics, Inc. | HNO | Class I | 2001-06-22 |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | HPZ | Class II | 2001-06-19 |
| K011577 | OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S | Ocu-Ease Optical Products, Inc. | LPL | Class II | 2001-06-19 |
| K011316 | BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T | American Contact Lens, Inc. | LPL | Class II | 2001-06-13 |
| K011234 | BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L | American Biocurve, Inc. | LPL | Class II | 2001-06-13 |
| K010315 | ISCREEN VISION SCREENER | Iscreen, LLC | HKI | Class II | 2001-06-01 |
| K011089 | SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C | Specialty Ultravision, Inc. | LPL | Class II | 2001-05-23 |
| K004049 | POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) | Optech, Inc. | LPL | Class II | 2001-05-23 |
| K003442 | MODIFICATION TO EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | HLX | Class II | 2001-05-04 |
| K010305 | WEISS RETINAL CANNULA | Micron Surgical, Inc. | HMX | Class I | 2001-05-02 |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | Heinz Kurz GmbH Medizintechnik | MML | Class II | 2001-05-02 |
| K010353 | MED-LOGICS DISPOSABLE ALK TUBING | Med-Logics, Inc. | KYG | Class I | 2001-04-27 |
| K010260 | HANSATOME MICROKERATOME | Bausch & Lomb, Inc. | HNO | Class I | 2001-04-27 |
| K003842 | PRESCOTT'S SURGICAL SPEAR | Prescott'S, Inc. | HOZ | Class II | 2001-04-13 |
| K010507 | VISTAKON (METHAFILCON A) CONTACT LENSES | Vistakon | LPL | Class II | 2001-04-12 |
| K010114 | ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2001-04-11 |
| K010256 | ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL | Opti-Centre Laboratories | LPL | Class II | 2001-03-26 |
| K003345 | AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | LPN | Class II | 2001-03-26 |
| K010636 | FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT | Ciba Vision Corporation | MVN | Class II | 2001-03-23 |
| K010223 | BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) | American Contact Lens, Inc. | LPL | Class II | 2001-03-16 |
| K010218 | VISTAKON (HEFILCON C) CONTACT LENSES | Vistakon | LPL | Class II | 2001-03-16 |
| K010126 | PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Cl-Tinters | LPL | Class II | 2001-03-12 |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | HQE | Class II | 2001-03-12 |
| K003594 | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME | Moria, Inc. | HMY | Class I | 2001-03-09 |
| K003299 | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 | Nidek Co., Ltd. | HLQ | Class I | 2001-03-09 |
| K003861 | BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) | Benz Research and Development Corp. | LPL | Class II | 2001-03-08 |
| K003826 | FOCUS DAILIES PROGRESSIVES | Ciba Vision Corporation | MVN | Class II | 2001-03-08 |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | Oasis Medical, Inc. | HNO | Class I | 2001-03-08 |
| K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK | Paragon Vision Sciences | MUW | Class II | 2001-02-28 |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | Iop, Inc. | MML | Class II | 2001-02-22 |
| K002515 | MEDLOGICS ML 4000, MODEL 4000 | Med-Logics, Inc. | HNO | Class I | 2001-02-22 |
| K003996 | OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR | Ocu-Ease Optical Products, Inc. | LPL | Class II | 2001-02-21 |
| K004000 | OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT | Ocu-Ease Optical Products, Inc. | LPL | Class II | 2001-02-21 |
| K003789 | SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT | Specialty Ultravision, Inc. | LPL | Class II | 2001-02-21 |
| K003252 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | LPN | Class II | 2001-02-21 |
| K003932 | BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY | Polymer Technology | HQD | Class II | 2001-02-16 |
| K003933 | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | Polymer Technology | MUW | Class II | 2001-02-16 |
| K001585 | BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE | American Biocurve, Inc. | LPL | Class II | 2001-02-13 |
| K003833 | SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Clearlab Pte , Ltd. | LPL | Class II | 2001-02-13 |
| K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | Allergan, Inc. | HQC | Class II | 2001-02-13 |
| K003526 | SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) | Specialty Ultravision, Inc. | LPL | Class II | 2001-02-12 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.