Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 36
- Latest Decision
- 2001-02-08
Clearances · page 16 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K003512 | LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II | A.R.C. Laser AG | HQC | Class II | 2001-02-08 |
| K003586 | FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES | Ciba-Geigy Corp. | MVN | Class II | 2001-02-08 |
| K003338 | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | HPZ | Class II | 2001-02-07 |
| K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | Welch Allyn, Inc. | HLI | Class II | 2001-01-25 |
| K003042 | V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT | Joe B. Goldberg, O.D. | LPL | Class II | 2001-01-22 |
| K003136 | OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Ocular Sciences Puerto Rico, Inc. | LPL | Class II | 2001-01-06 |
| K003768 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | MSS | Class I | 2001-01-05 |
| K003031 | LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML | Alpha Vista, Inc. | LPN | Class II | 2001-01-05 |
| K002932 | PHACOGARD | Syntec, Inc. | HQC | Class II | 2001-01-04 |
| K002031 | PHACOFRAGMENTATION SYSTEM MEGATRON | Asclepion-Meditec AG | HQC | Class II | 2000-12-27 |
| K003036 | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 | Retinalabs.Com | KYG | Class I | 2000-12-22 |
| K003305 | PEDIATRIC INGESTASCAN | Adams Electronics, Inc. | HPM | Class II | 2000-12-22 |
| K002920 | MEGAVISION CPX, MEGAVISION FA, MODEL I AND II | Escalon Medical Corp. | HKI | Class II | 2000-12-18 |
| K003170 | RYTHMIC AND RYTHMIC UV | Essilor Intl. | LPL | Class II | 2000-12-15 |
| K003161 | ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT | Les Laboratoires Blanchard | LPL | Class II | 2000-12-15 |
| K003071 | GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Ciba Vision Corporation | LPL | Class II | 2000-12-13 |
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Xomed, Inc. | HKX | Class II | 2000-12-11 |
| K003143 | MILLENNIUM BLADES, MODEL MB101 | Millennium Biomedical, Inc. | HNO | Class I | 2000-12-11 |
| K002845 | PAFLUFOCON C AND E DAILY CONTACT LENS | Paragon Vision Sciences | HQD | Class II | 2000-12-08 |
| K002986 | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 | A.R.C. Laser AG | HQC | Class II | 2000-11-29 |
| K003079 | SPECIALTY TINT SOFT CONTACT LENS | Specialty Tint | LPL | Class II | 2000-11-21 |
| K002703 | O-PERM 30 | Optical Polymer Research, Inc. | HQD | Class II | 2000-11-21 |
| K003109 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | LPN | Class II | 2000-11-21 |
| K002966 | OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR | Ocu-Ease Optical Products, Inc. | LPL | Class II | 2000-11-08 |
| K002812 | IRIS RETRACTING PHACOEMULSIFICATION SLEEVE | Michael Reynard, M.D. | HQC | Class II | 2000-11-08 |
| K003236 | RETINADX | Regulatory Associates, Inc. | HKI | Class II | 2000-11-02 |
| K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | Pharmacia & Upjohn Co. | MSS | Class I | 2000-10-31 |
| K002025 | RIGID GAS PERMEABLE CONTACT LENS | Polymer Technology | HQD | Class II | 2000-10-31 |
| K002589 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | LPN | Class II | 2000-10-23 |
| K002341 | THERMAL CAUTERY UNIT, MODEL 150 | Geiger Medical Technologies, Inc. | HQO | Class II | 2000-10-23 |
| K991124 | VISIJET HYDROKERATOME, MODEL 50 | Visijet, Inc. | MYD | Class I | 2000-10-20 |
| K994320 | CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES | Cantor & Silver , Ltd. | NCZ | Class II | 2000-10-20 |
| K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | Starion Instruments | HQP | Class II | 2000-10-20 |
| K002510 | SMARTLENS | Odc Ophthalmic Development Co. AG | HKX | Class II | 2000-10-18 |
| K002849 | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES | Surgical Specialties Corp | HNO | Class I | 2000-10-18 |
| K002823 | RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION | Bausch & Lomb, Inc. | LPN | Class II | 2000-10-17 |
| K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS | Unilens Corp., USA | LPL | Class II | 2000-10-17 |
| K002191 | CARRIAZO BARRAQUER II MICROKERATOME | Moria, Inc. | HMY | Class I | 2000-10-12 |
| K002140 | MENICON PROGENT REMOVER | Menicon Co, Ltd. | MRC | Class II | 2000-10-10 |
| K001125 | GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING | Geuder GmbH | NCE | Class I | 2000-10-04 |
| K001464 | DISPOSABLE H-PE MICROKERATOME BLADES | Oasis | HNO | Class I | 2000-10-02 |
| K000975 | LIPIDURE REWETTING DROPS | Nof Corp. | MRC | Class II | 2000-09-25 |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | Oasis Medical, Inc. | HNO | Class I | 2000-09-21 |
| K994340 | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ | Hai Laboratories, Inc. | HLI | Class II | 2000-09-20 |
| K002625 | METHAFILCON A | CooperVision, Inc. | LPL | Class II | 2000-09-13 |
| K002647 | MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS | Marietta Contact Lens Service | LPL | Class II | 2000-09-13 |
| K002044 | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | Magna Fortis Corporation | HLJ | Class II | 2000-09-12 |
| K001806 | REFRACTIVE SURGERY BLADES | Millennium Biomedical, Inc. | HNO | Class I | 2000-09-12 |
| K002319 | PURILENS SALINE SOLUTION | Purilens, Inc. | LPN | Class II | 2000-08-30 |
| K001960 | RIGID GAS PERMEABLE CONTACT LENS | Polymer Technology | HQD | Class II | 2000-08-28 |
| K001908 | KONTUR 55 SOFT LENS | Kontur Kontact Lens Co., Inc. | LPL | Class II | 2000-08-18 |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | Med-Logics, Inc. | HOZ | Class II | 2000-08-18 |
| K001498 | THE FUGO BLADE | Medisurg , Ltd. | NCR | Class II | 2000-08-10 |
| K001539 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | LPN | Class II | 2000-07-31 |
| K001964 | OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION | Lobob Laboratories, Inc. | MRC | Class II | 2000-07-18 |
| K001275 | RETCAM II | Massie Research Laboratories, Inc. | HKI | Class II | 2000-07-13 |
| K001214 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | LPN | Class II | 2000-07-10 |
| K001111 | PANORET, MODEL 1000A | Cmt Medical Technologies, Ltd. | HKL | Class II | 2000-07-07 |
| K001772 | LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA | Taracan Pty. , Ltd. | HQF | Class II | 2000-07-06 |
| K001235 | OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 | Alcon Universal, Ltd. | MRC | Class II | 2000-07-03 |
| K001227 | ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT | Opti-Centre Laboratories | LPL | Class II | 2000-06-29 |
| K001157 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | KYB | Class I | 2000-06-27 |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Canon USA, Inc. | HLI | Class II | 2000-06-21 |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | Starion Instruments | HQO | Class II | 2000-06-14 |
| K001620 | METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN | Metro Optics of Austin, Inc. | LPL | Class II | 2000-06-13 |
| K001326 | NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON | Ocular Concepts, LLC | NCK | Class I | 2000-06-13 |
| K001584 | METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT | Medvice Consulting, Inc. | LPL | Class II | 2000-06-13 |
| K991206 | BONASSE CONTACT LENS CASE | Bonasse Ent. Co., Ltd. | LRX | Class II | 2000-06-06 |
| K992835 | C.S.O. TONOMETER | Cso | HKY | Class II | 2000-06-06 |
| K000998 | OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES | Optisonic, Inc. | LPN | Class II | 2000-06-05 |
| K000164 | COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION | Allergan, Inc. | LPN | Class II | 2000-06-02 |
| K001428 | OPTIMUM WETTING AND REWETTING DROP | Lobob Laboratories, Inc. | MRC | Class II | 2000-05-26 |
| K000795 | RIGID GAS PERMEABLE CONTACT LENS | Polymer Technology | HQD | Class II | 2000-05-26 |
| K993586 | SPORTSIGHT GP | Paragon Vision Sciences | HQD | Class II | 2000-05-22 |
| K000133 | MENICON Z | Menicon U.S.A., Inc. | HQD | Class II | 2000-05-19 |
| K000637 | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) | Alcon Laboratories, Inc. | NCF | Class I | 2000-05-19 |
| K001089 | POLYMACON | CooperVision, Inc. | LPL | Class II | 2000-05-19 |
| K000233 | MENICON SF-P | Menicon Co, Ltd. | HQD | Class II | 2000-05-19 |
| K001090 | METHAFILCON A | CooperVision, Inc. | LPL | Class II | 2000-05-19 |
| K000607 | SOLO-CARE BRAND HARD SOLUTION | Ciba Vision Corporation | MRC | Class II | 2000-05-15 |
| K000485 | HYDRO2, HS-75 | Innovision, Inc. | HQD | Class II | 2000-05-12 |
| K994362 | HEADLAMP HL2000. | Angiolaz, Inc. | FSR | Class II | 2000-05-11 |
| K000457 | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES | Retinalabs.Com | HMX | Class I | 2000-05-09 |
| K001144 | ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS | Lasersight Technologies, Inc. | HNO | Class I | 2000-05-05 |
| K000368 | EYECAP IMAGING SYSTEM | Clement Clarke Intl., Ltd. | HKI | Class II | 2000-05-04 |
| K000327 | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 | Visx, Incorporated | HKO | Class I | 2000-05-02 |
| K000385 | OPTI-FREE EXPRESS LENS DROPS | Alcon Universal, Ltd. | MRC | Class II | 2000-04-28 |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | Heinz Kurz GmbH Medizintechnik | MML | Class II | 2000-04-21 |
| K000247 | BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER | Bausch & Lomb, Inc. | LPN | Class II | 2000-04-20 |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | HPZ | Class II | 2000-04-19 |
| K000224 | FLUROPERM 60-OK, PARAGON HDS-OK | Paragon Vision Sciences | MUW | Class II | 2000-04-17 |
| K994289 | SUTUREGROOVE | Iop, Inc. | MML | Class II | 2000-04-17 |
| K993489 | CRYSTAL CUSTOM TINTED SOFT CONTACT LENS | Crystal Reflections, Int., Inc. | LPL | Class II | 2000-04-14 |
| K000127 | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | Heinz Kurz GmbH Medizintechnik | MML | Class II | 2000-04-12 |
| K000148 | RGP MULTI-PURPOSE SOLUTION ID 100136 | Alcon Laboratories | MRC | Class II | 2000-04-11 |
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Integrated Orbital Implants, Inc. | MQU | Class II | 2000-04-10 |
| K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | HLI | Class II | 2000-03-31 |
| K000288 | REICHERT CT200 CONTACT TONOMETER | Reichert Ophthalmic Instruments, Div. Leica, Inc. | HKY | Class II | 2000-03-23 |
| K000376 | SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT | Specialty Ultravision, Inc. | LPL | Class II | 2000-03-21 |
| K000529 | LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) | The Lifestyle Co., Inc. | LPL | Class II | 2000-03-21 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.