Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 30
- Latest Decision
- 2008-08-28
Clearances · page 11 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K082132 | BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK | Bausch & Lomb, Inc. | HQC | Class II | 2008-08-28 |
| K081756 | OCULAR RESPONSE ANALYZER | Reichert, Inc. | HKX | Class II | 2008-08-07 |
| K082043 | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | HNO | Class I | 2008-08-01 |
| K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | Appasamy Associates | HJO | Class II | 2008-07-31 |
| K080512 | REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | Metro Optics of Austin, Inc. | LPL | Class II | 2008-07-23 |
| K080672 | BIRTHTRACK | Barnev, Ltd. | NPB | Class II | 2008-07-08 |
| K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | Art Optical Contact Lens, Inc. | LPL | Class II | 2008-07-03 |
| K081565 | INTEGRE PRO, MODEL L2RY | Ellex Medical Pty, Ltd. | HQF | Class II | 2008-07-02 |
| K072861 | CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) | Acheve Technology, Inc. | HJO | Class II | 2008-06-24 |
| K072985 | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | Duckworth & Kent, Ltd. | KYB | Class I | 2008-06-20 |
| K080180 | MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) | Optical Imaging , Ltd. | HKI | Class II | 2008-06-11 |
| K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | MVN | Class II | 2008-06-10 |
| K071755 | FALCK APPLANATION TONOMETER (FAT2) | Falck Medical, Inc. | HKY | Class II | 2008-06-03 |
| K081034 | SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS | Synergeyes, Inc. | HQD | Class II | 2008-05-30 |
| K063583 | ALCON VISION SYSTEM | Alcon | HQC | Class II | 2008-05-09 |
| K072259 | OPHTHALMOSCOPE F-10 | Nidek Co., Ltd. | MYC | Class II | 2008-05-06 |
| K080883 | CR-1 | Canon, Inc. | HKI | Class II | 2008-04-24 |
| K080686 | WESTCON HORIZON 49% (HIOXIFILCON B) | Westcon Contact Lens Co. | LPL | Class II | 2008-04-22 |
| K080681 | KOWA GENESIS-D | Kowa Co. , Ltd. | HKI | Class II | 2008-04-04 |
| K073293 | DURETTE IMPLANT | Oculo Plastik, Inc. | HPZ | Class II | 2008-03-19 |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | MSS | Class I | 2008-03-13 |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | MSS | Class I | 2008-03-13 |
| K073023 | STERILS SINGLE-USE I/A HANDPIECES | Bausch & Lomb, Inc. | HQC | Class II | 2008-03-12 |
| K080423 | INTEGRE, MODEL LP581 | Ellex Medical Pty, Ltd. | HQF | Class II | 2008-03-11 |
| K080193 | SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR | Synergeyes, Inc. | HQD | Class II | 2008-03-05 |
| K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2008-03-03 |
| K073459 | CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES | Ciba Vision Corporation | LPL | Class II | 2008-02-28 |
| K071839 | SOCT COPERNICUS, MODEL 15205 | Reichert, Inc. | OBO | Class II | 2008-02-27 |
| K062763 | NONCON ROBO PACHY F&A | Konan Medical, Inc. | NQE | Class II | 2008-02-22 |
| K073184 | BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS | Bausch & Lomb, Inc. | HQD | Class II | 2008-02-21 |
| K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Ciba Vision Corporation | LPL | Class II | 2008-01-24 |
| K073190 | SLIT LAMP | Huvitz Co., Ltd. | HJO | Class II | 2008-01-11 |
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | CooperVision, Inc. | LPL | Class II | 2008-01-04 |
| K072823 | MERILAS 532A | Meridian AG | HQF | Class II | 2007-12-14 |
| K071236 | ALCON MULTI-PURPOSE SOLUTION | Alcon, Inc. | LPN | Class II | 2007-12-12 |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Innova Vision, Inc. | MVN | Class II | 2007-11-29 |
| K073010 | ROYALE AE 9036 LSP INJECTOR | Asico, LLC | MSS | Class I | 2007-11-07 |
| K070270 | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | Kirchner & Wilhelm GmbH + Co.Kg | HLJ | Class II | 2007-11-05 |
| K062624 | NEXT GENERATION LASER | Alcon Laboratories | HQF | Class II | 2007-11-05 |
| K070669 | IOL INJECTOR SET | Medicel AG | KYB | Class I | 2007-11-01 |
| K071250 | CA, MODEL: CAM | Optovue, Inc. | OBO | Class II | 2007-09-28 |
| K063297 | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR | Lightmed Corp. | HQF | Class II | 2007-09-20 |
| K071266 | BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS | Bausch & Lomb, Inc. | HQD | Class II | 2007-08-15 |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | HPZ | Class II | 2007-08-08 |
| K062854 | BENZ-G 4X HIOXIFILCON D | Benz Research and Development Corp. | LPL | Class II | 2007-08-06 |
| K071043 | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | Bausch & Lomb, Inc. | HQD | Class II | 2007-08-02 |
| K063310 | TRUEFIELD ANALYZER | Seeing Machines Limited | HPT | Class I | 2007-08-02 |
| K070767 | EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION | Lapis Lazuli International NV | LPN | Class II | 2007-07-24 |
| K071183 | ALLEGRO OCULYZER | Wavelight AG | MXK | Class II | 2007-07-20 |
| K063388 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Topcon Corp. | OBO | Class II | 2007-06-22 |
| K071203 | SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES | Optikem International, Inc. | LPN | Class II | 2007-06-13 |
| K062541 | CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Innova Vision, Inc. | LPL | Class II | 2007-06-07 |
| K063873 | ICARE TONOMETER TA01I | Tiolat OY | HKY | Class II | 2007-05-23 |
| K063802 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | MSS | Class I | 2007-05-07 |
| K070637 | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES | Paragon Vision Sciences | HQD | Class II | 2007-05-01 |
| K071081 | CONTACT LENS CASE | Ningbo Kaida Rubber and Plastic Technology Co., LT | LRX | Class II | 2007-05-01 |
| K070628 | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. | Contamac, Ltd. | HQD | Class II | 2007-05-01 |
| K062332 | ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION | Altaire Pharmaceuticals, Inc. | LPN | Class II | 2007-04-25 |
| K070231 | ORION | Nidek Technologies Srl | HKI | Class II | 2007-04-24 |
| K070776 | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR | Quantel Medical | HQF | Class II | 2007-04-24 |
| K070130 | ORBITAL RECONSTRUCTIVE IMPLANT | Becker & Associates Consulting, Inc. | HPZ | Class II | 2007-04-19 |
| K070871 | STARION UNIVERSAL POWER SUPPLY | Starion Instruments | HQO | Class II | 2007-04-13 |
| K070534 | MODIFICATION TO: OCU-FILM TIP COVER | Reichert, Inc. | HKY | Class II | 2007-03-27 |
| K063155 | MONARCH III IOL DELIVERY SYSTEM | Alcon Manufacturing, Ltd. | KYB | Class I | 2007-03-27 |
| K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | Alliance Medical Corp. | NKX | Class II | 2007-03-19 |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | Takagi Seiko Co., Ltd. | HJO | Class II | 2007-03-13 |
| K070308 | FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR | X-Cel Contacts | LPL | Class II | 2007-03-12 |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | Kirwan Surgical Products, Inc. | HQP | Class II | 2007-03-09 |
| K063694 | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 | Bausch & Lomb, Inc. | KYB | Class I | 2007-03-07 |
| DEN060006 | COMPUTERIZED LABOR MONITORING SYSTEM | Barnev, Ltd. | NPB | Class II | 2007-01-30 |
| K063378 | CIRRUS HD-OCT, MODEL 4000 | Carl Zeiss Meditec, Inc. | HLI | Class II | 2007-01-26 |
| K063717 | CF-1 | Canon, Inc. | HKI | Class II | 2007-01-23 |
| K063750 | XCEL 255 SLIT LAMP | Reichert, Inc. | HJO | Class II | 2006-12-20 |
| K063331 | BAUSCH & LOMB NGX MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | HQC | Class II | 2006-12-19 |
| K063640 | KOWA SL-15 | Kowa Co. , Ltd. | HJO | Class II | 2006-12-18 |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Bioptigen, Inc. | HLI | Class II | 2006-12-13 |
| K062612 | RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 | Rayner Surgical, Inc. | MSS | Class I | 2006-12-13 |
| K063416 | LUXVISION SLIT LAMP | Us Ophthalmic, LLC | HJO | Class II | 2006-12-07 |
| K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | CooperVision, Inc. | MVN | Class II | 2006-11-22 |
| K062416 | RETINAL FUNCTIONAL IMAGER (RFI) | Optical Imaging , Ltd. | HKI | Class II | 2006-11-17 |
| K062262 | CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS | Ciba Vision Corporation | LPL | Class II | 2006-11-14 |
| K062074 | IRIDEX WIRELESS FOOTSWITCH | Iridex Corp | HQF | Class II | 2006-11-14 |
| K062930 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Research, Ltd. | NCF | Class I | 2006-11-08 |
| K052599 | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A | Suzhou 66 Vision Tech Co., Ltd. | HLJ | Class II | 2006-11-07 |
| K062412 | CRYOMATIC | Keeler Instruments, Inc. | HRN | Class II | 2006-11-06 |
| K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2006-11-01 |
| K062548 | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | Contamac, Ltd. | HQD | Class II | 2006-11-01 |
| K062021 | KOWA VX-10I | Kowa Co. , Ltd. | HKI | Class II | 2006-11-01 |
| K063191 | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT | Heidelberg Engineering | OBO | Class II | 2006-10-31 |
| K062295 | IRI INTEGRATED RETINAL IMAGER | Medivision Medical Imaging, Ltd. | HKI | Class II | 2006-10-20 |
| K062552 | RTVUE | Optovue, Inc. | OBO | Class II | 2006-10-06 |
| K061768 | MP-1 MICROPERIMETER | Nidek Technologies Srl | HKI | Class II | 2006-09-28 |
| K062356 | KOWA NONMYD ALPHA-D | Kowa Co. , Ltd. | HKI | Class II | 2006-09-27 |
| K062252 | MOLTENO3 | Iop, Inc. | KYF | Class II | 2006-09-27 |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | New World Medical, Inc. | KYF | Class II | 2006-09-18 |
| K062465 | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | HNO | Class I | 2006-09-06 |
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | HLI | Class II | 2006-08-23 |
| K060151 | ORBITAL TISSUE EXPANDER (OTE) | Innovia, LLC | NFM | Class II | 2006-08-08 |
| K060924 | JSZ MULTIACTION GP CONTACT LENS SOLUTION | Szabocsik and Associates | LPN | Class II | 2006-06-28 |
| K061120 | SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES | Synergeyes, Inc. | HQD | Class II | 2006-06-22 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.