Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 32
- Latest Decision
- 2006-06-22
Clearances · page 12 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb | MVN | Class II | 2006-06-22 |
| K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | Peregrine Surgical , Ltd. | HQF | Class II | 2006-06-21 |
| K053444 | KOWA KT-800 | Kowa Co. , Ltd. | HKX | Class II | 2006-06-09 |
| K051104 | EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION | Lapis Lazuli, NV | LPN | Class II | 2006-05-31 |
| K061330 | PSL PORTABLE SLIT LAMP | Reichert, Inc. | HJO | Class II | 2006-05-25 |
| K052674 | CONTACT LENS OPHTHALMODYNAMOMETER | Meditron, GmbH | NYK | Class II | 2006-05-24 |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | HLI | Class II | 2006-05-23 |
| K060995 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 | Duckworth & Kent, Ltd. | MSS | Class I | 2006-05-22 |
| K060821 | SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES | Specialeyes, LLC | LPL | Class II | 2006-05-18 |
| K061278 | OPTYSE OPHTHALMOSCOPE | Ophthalmos , Ltd. | HLJ | Class II | 2006-05-16 |
| K052290 | AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS | Clearlab Pte , Ltd. | LPL | Class II | 2006-05-15 |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | MVN | Class II | 2006-05-15 |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | Innova Vision, Inc. | MVN | Class II | 2006-05-12 |
| K060869 | RS-1000 ZOOM SLITLAMP WITH OPTION | Rightmedical Products, LLC | HJO | Class II | 2006-05-11 |
| K053298 | ALPHASPHERE ORBITAL IMPLANT | Hydron Pty Limited | HPZ | Class II | 2006-05-09 |
| K060533 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM | Lenstec, Inc. | MSS | Class I | 2006-04-14 |
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | Advanced Medical Optics, Inc. | HQC | Class II | 2006-04-07 |
| K060780 | TONOMETER DIATON | Ryazan State Instruments | HKX | Class II | 2006-04-06 |
| K052891 | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | HNO | Class I | 2006-03-23 |
| K060424 | PANORAMIC, MODEL 200MA | Optos Plc. | MYC | Class II | 2006-03-17 |
| K051684 | EYEPORT VISION TRAINING SYSTEM | Exercise Your Eyes, Inc. | NXR | Class I | 2006-03-17 |
| K053622 | SURGISIS OCULAR GRAFT | Iop, Inc. | NXM | Class II | 2006-03-15 |
| K060102 | SYNERGEYES PS HYBRID CONTACT LENS | Synergeyes, Inc. | HQD | Class II | 2006-03-15 |
| K051477 | MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) | Mi Gwang Contact Lens Co., Ltd. | LPL | Class II | 2006-03-10 |
| K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER | Medtronic Xomed, Inc. | HKY | Class II | 2006-03-03 |
| K053475 | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | Refractec, Inc. | HMR | Class I | 2006-03-03 |
| K052983 | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES | Paragon Vision Sciences | HQD | Class II | 2006-02-10 |
| K053124 | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | Bausch & Lomb, Incorporated | HQD | Class II | 2006-01-30 |
| K053176 | DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 | Duckworth & Kent, Ltd. | MSS | Class I | 2006-01-30 |
| K053044 | OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 | Opto Global, Inc. | HKI | Class II | 2006-01-24 |
| K052651 | C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 | Rayner Surgical, Inc. | MSS | Class I | 2006-01-19 |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Heidelberg Engineering | MXK | Class II | 2006-01-13 |
| K053425 | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | Precision Optics Corp. | HLJ | Class II | 2006-01-09 |
| K052606 | MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS | Marietta Vision | LPL | Class II | 2005-12-15 |
| K050933 | FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 | Medisurg , Ltd. | NCR | Class II | 2005-12-09 |
| K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | CooperVision, Inc. | LPL | Class II | 2005-12-06 |
| K052675 | SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS | Synergeyes | HQD | Class II | 2005-11-30 |
| K052703 | ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL | Alden Optical Labs., Inc. | LPL | Class II | 2005-11-10 |
| K053026 | KOWA NONMYD 7, KOWA NONMYD A-D | Kowa Co. , Ltd. | HKI | Class II | 2005-11-10 |
| K050271 | KOWA GENESIS-D HAND-HELD RETINAL CAMERA | Kowa Co. , Ltd. | HKI | Class II | 2005-11-03 |
| K052507 | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR | The Lagado Corp. | HQD | Class II | 2005-11-02 |
| K052268 | VISUCAM PRO NM | Carl Zeiss Meditec, AG | HKI | Class II | 2005-11-02 |
| K052809 | SAUFLON FLAT COLOURED LENS CASE | Sauflon Pharmaceuticals, Ltd. | LRX | Class II | 2005-11-02 |
| K043213 | KOWA VX-10 | Kowa Co. , Ltd. | HKI | Class II | 2005-10-06 |
| K051789 | VISANTE OCT | Carl Zeiss Meditec, Inc. | HLI | Class II | 2005-09-30 |
| K051944 | FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES | Lumenis, Inc. | HQF | Class II | 2005-09-30 |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | MXK | Class II | 2005-09-28 |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Alliance Medical, Inc. | NKX | Class II | 2005-09-23 |
| K050807 | 20G SMA LASER FIBER, MODEL LF100 | Ophthalmed, LLC | HQF | Class II | 2005-09-21 |
| K050729 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | LPN | Class II | 2005-09-14 |
| K041820 | SOLO-CARE AQUA ANTIMICROBIAL LENS CASE | Ciba Vision Corporation | LRX | Class II | 2005-09-09 |
| K051035 | SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS | Synergeyes | HQD | Class II | 2005-09-02 |
| K052074 | JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, | Szabocsik and Associates | MRC | Class II | 2005-09-01 |
| K050336 | OPD-STATION SOFTWARE | Nidek, Inc. | NCF | Class I | 2005-08-24 |
| K051186 | MICROPULSE PHACOEMULSIFICATION SYSTEM | Trillium Medical, Inc. | HQC | Class II | 2005-08-18 |
| K051095 | 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Optical Connection, Inc. | LPL | Class II | 2005-08-16 |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | Johnson & Johnson Vision Care, Inc. | MVN | Class II | 2005-08-12 |
| K051129 | DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Innova Vision, Inc. | LPL | Class II | 2005-08-12 |
| K050250 | AQUIFY MULTIPURPOSE SOLUTION | Ciba Vision Corporation | LPN | Class II | 2005-08-10 |
| K042562 | LENS PLUS REWETTING DROPS | Advanced Medical Optics, Inc. | LPN | Class II | 2005-07-29 |
| K051430 | EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) | Hydrogel Vision Corporation | LPL | Class II | 2005-07-18 |
| K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | HNO | Class I | 2005-07-06 |
| K051184 | 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | United Contact Lens, Inc. | LPL | Class II | 2005-07-01 |
| K041008 | EYE-CEPT REWETTING DROPS | Optics Laboratory, Inc. | LPN | Class II | 2005-07-01 |
| K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET | Insight Instruments, Inc. | HJK | Class II | 2005-06-29 |
| K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | Haag-Streit USA, Inc. | HJK | Class II | 2005-06-07 |
| K050856 | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | Ophthocare , Ltd. | HOY | Class I | 2005-05-31 |
| K050638 | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES | Lenstec, Inc. | MSS | Class I | 2005-05-31 |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | Ciba Vision Corporation | MVN | Class II | 2005-05-27 |
| K050948 | PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | LPL | Class II | 2005-05-18 |
| K050717 | PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC | CooperVision, Inc. | LPL | Class II | 2005-05-13 |
| K050541 | OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY | Omniguide Communications, Inc. | HQF | Class II | 2005-05-09 |
| K050350 | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) | Notal Vision, Inc. | HPT | Class I | 2005-04-29 |
| K050157 | MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS | Bausch & Lomb, Inc. | LPL | Class II | 2005-04-26 |
| K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS | Unilens Corp., USA | LPL | Class II | 2005-04-13 |
| K050517 | JSZ-MULTIPURPOSE SOLUTION | Szabocsik and Associates | LPN | Class II | 2005-04-13 |
| K043503 | VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 | Visx, Incorporated | HJO | Class II | 2005-04-05 |
| K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK | Advanced Medical Optics, Inc. | HQC | Class II | 2005-04-05 |
| K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D | Volk Optical, Inc. | HJK | Class II | 2005-03-28 |
| K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | Ciba Vision Corporation | MVN | Class II | 2005-03-28 |
| K043183 | EPI-K | Moria SA | HNO | Class I | 2005-03-25 |
| K043613 | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II | Quantel Medical | HQF | Class II | 2005-03-24 |
| K050308 | THERMAL CAUTERY PROBE | Starion Instruments | HQR | Class II | 2005-02-25 |
| K043222 | VISCUCAM C DIGITAL CAMERA | Carl Zeiss Meditec, AG | HKI | Class II | 2005-02-14 |
| K043236 | FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA | Quantel Medical | HQF | Class II | 2005-02-07 |
| K040303 | 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS | Hydrogel Vision Corporation | LPL | Class II | 2005-02-02 |
| K043540 | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES | Westcon Contact Lens Co., Inc. | LPL | Class II | 2005-02-01 |
| K043150 | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | HNO | Class I | 2005-01-31 |
| K041841 | PACHYCAM | Oculus Optikgerate GmbH | MXK | Class II | 2005-01-28 |
| K042578 | I-PROMOTIONS CONTACT LENS CASE | I-Promotions, Inc. | LRX | Class II | 2005-01-25 |
| K042885 | OCT-OPTHALMOSCOPE | Ophthalmic Technologies, Inc. | HLI | Class II | 2005-01-21 |
| K043129 | PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) | Opti-Centre Laboratories | LPL | Class II | 2005-01-12 |
| K042478 | CAPSULE TENSION RING INSERTER, MODEL 7-810 | Duckworth & Kent, Ltd. | NCE | Class I | 2004-12-28 |
| K042099 | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | Retinapharma Technologies, Inc. | HKX | Class II | 2004-12-10 |
| K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) | Starion Instruments | HQO | Class II | 2004-12-09 |
| K033146 | TONO-PEN TONOMETER TIP COVER | Tra & Accessories | HKY | Class II | 2004-11-23 |
| K042824 | FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | CooperVision, Inc. | LPL | Class II | 2004-11-16 |
| K042083 | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | HNO | Class I | 2004-11-16 |
| K041367 | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | HKI | Class II | 2004-11-05 |
| K042176 | AQUIFY LENS COMFORT DROPS | Ciba Vision Corporation | LPN | Class II | 2004-11-03 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.