Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 28
- Latest Decision
- 1995-08-14
Clearances · page 23 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K941084 | SUNGLASSES | Blue Gem Sunglasses, Inc. | HQY | Class I | 1995-08-14 |
| K951801 | MING-YA OPTICAL INDUSTRIALCO., LTD. | Min-Ya Optical Industrial Co., Ltd. | HQY | Class I | 1995-08-14 |
| K952213 | ALCON SERIES 20000 LEGACY PHACOEMULSIFIER | Alcon Laboratories | HQC | Class II | 1995-08-09 |
| K952734 | HENNERT SA | Hennert S.A. | HQY | Class I | 1995-08-08 |
| K952758 | GOUVERNEUR AUDIGIER | Ets Gouverneur-Audigier | HQY | Class I | 1995-08-07 |
| K953078 | STORZ DP4101 BASIC I/A PACK | Storz Instrument Co. | HQC | Class II | 1995-08-07 |
| K953473 | SUNGLASSES (NON-PRESCRIPTION) | Cbi Dist. | HQY | Class I | 1995-08-07 |
| K952939 | ROYAL FLASH | Royal Flash Enterprise Co. , Ltd. | HQY | Class I | 1995-08-07 |
| K953413 | OPTX 20/20 | Neoptx, Inc. | HQY | Class I | 1995-08-07 |
| K952258 | HURRICANE | Hurricane Hardware, Inc. | HQY | Class I | 1995-07-31 |
| K952152 | PROCLEAR DAILY WEAR CONTACT LENS | Biocompatibles , Ltd. | LPL | Class II | 1995-07-27 |
| K944872 | BIO-COR COLLAGEN CORNEAL SHIELD | Bausch & Lomb Healthcare and Optics Worldwide | MOE | Class I | 1995-07-26 |
| K950968 | TETRAFILCON A HYDROPHILIC CONTACT LENSES | CooperVision, Inc. | LPL | Class II | 1995-07-25 |
| K950914 | RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V | Rudolf Riester GmbH & Co. KG | HLJ | Class II | 1995-07-24 |
| K951824 | STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) | Nidek, Inc. | HQC | Class II | 1995-07-19 |
| K953260 | SUNGLASSES | Eye Deals | HQY | Class I | 1995-07-19 |
| K945443 | BOBES LENS SET | Bobes S.A. | HPC | Class I | 1995-07-19 |
| K953245 | NYX GOLF VISION SYSTEM | Nyx Golf, Inc. | HQY | Class I | 1995-07-19 |
| K953092 | FOSTER GRANT NON PRESCRIPTION SUNGLASSES | Foster Grant Group | HQY | Class I | 1995-07-19 |
| K950218 | OMS SLIMLINE PHACO HANDPIECE | Optical Micro Systems, Inc. | HQC | Class II | 1995-07-17 |
| K951551 | FREDEIC BEAUSOCEIL | Pascal Mathieux | HQY | Class I | 1995-07-17 |
| K951979 | SUNGLASSES | Heyro Optical Manufactory | HQY | Class I | 1995-07-17 |
| K952289 | WELCH ALLYN FIBER OPTIC HEADLIGNT | Welch Allyn, Inc. | HPQ | Class II | 1995-07-14 |
| K952784 | OXBORO-MEDICAL CAUTERY TIP CLEANER | Oxboro Medical Intl., Inc. | HQP | Class II | 1995-07-13 |
| K952890 | SUNGLASSES | Isohyper | HQY | Class I | 1995-07-12 |
| K953030 | SLIT LAMP AIA 11 | Naveen Intl., Inc. | HJO | Class II | 1995-07-12 |
| K953002 | METAL FRAM WITH POLYCARBONATE LENS | Nakanishi Optical Products Corp. | HQY | Class I | 1995-07-12 |
| K946054 | DIPLOMAX | Optical Micro Systems, Inc. | HQC | Class II | 1995-07-11 |
| K952261 | HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% | Pilkington Barnes-Hind, Ltd. | LPL | Class II | 1995-07-05 |
| K952165 | TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS | Rand Scientific Corp. | HQD | Class II | 1995-06-30 |
| K951815 | SUNGLASSES | Fung Won Optical Mfg. Co. | HQY | Class I | 1995-06-26 |
| K951132 | ANGIOSCAN (AS STAND ALONE INSTRUMENT) | Carl Zeiss Meditec, Inc. | HLI | Class II | 1995-06-26 |
| K950940 | OPTI PADS | Karlen Mfg., Inc. | LYL | Class II | 1995-06-26 |
| K951552 | BOSTON CONTACT LENS CASE | Polymer Technology Corp. | LRX | Class II | 1995-06-26 |
| K952538 | ROBERT B. SCOTT PLASTIC ARTIFICAL | Robert B. Scott Ocularists of Florida, Inc. | HQH | Class I | 1995-06-26 |
| K945446 | BOBES TONOMETER | Bobes S.A. | HKY | Class II | 1995-06-20 |
| K951462 | AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM | Allergan Medical Optics | HQC | Class II | 1995-06-15 |
| K951341 | NEITZ SLIT LAMP SL-H2 | Neitz Instruments Company, Ltd. | HJO | Class II | 1995-06-15 |
| K952259 | STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES | Storz Instrument Co. | HQC | Class II | 1995-06-14 |
| K950077 | INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) | Par Vision Systems Corp. | MMQ | Class I | 1995-06-14 |
| K951337 | FIBER HEAD LIGHT FH-300 | Neitz Instruments Company, Ltd. | HPQ | Class II | 1995-06-08 |
| K950529 | PEREGRINE DIFFUSION LIGHT PIPE | Peregrine Surgical , Ltd. | HJM | Class II | 1995-06-07 |
| K941234 | NON-MYDRIATIC RETINAL CAMERA | Canon USA, Inc. | HKI | Class II | 1995-06-07 |
| K951210 | WELCH ALLYN VIDEO OPHTHALMOSCOPE | Welch Allyn, Inc. | HLI | Class II | 1995-06-06 |
| K951992 | FAIRY WORLD INC | Fairy World, Inc. | HQY | Class I | 1995-06-06 |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | KYB | Class I | 1995-06-02 |
| K950114 | STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM | Storz Instrument Co. | HQC | Class II | 1995-06-02 |
| K945270 | CUSTOM ARTIFICIAL HUMAN EYES | Daniel T Acosta | HQH | Class I | 1995-05-30 |
| K951179 | DIGITAL RETINOSCOPIC PHOTOMETER | Kudi Kalu, Inc. | HKO | Class I | 1995-05-30 |
| K940324 | SPECTACLE SUN GLASSES | Occhiali, International Eyewear | HQY | Class I | 1995-05-26 |
| K950880 | AOI UNIVERSAL ULTRASONIC HANDPIECE | American Optical Corp. | HQC | Class II | 1995-05-26 |
| K950807 | SUNBLOCKER SUNGLASSES | Blublocker Corp. | HQY | Class I | 1995-05-24 |
| K950798 | POSTERIOR CAPSULE SHIELD | Oasis Medical, Inc. | HQC | Class II | 1995-05-22 |
| K950800 | PRO-PAK FOR OMS DIPLOMATE | M. Imonti and Associates Inc., | HQC | Class II | 1995-05-22 |
| K950852 | CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP) | H.S. Intl. Co., Inc. | HQE | Class II | 1995-05-19 |
| K951182 | RYDER CONTACT LENS CASE MODEL 10670 | Bradstreet Clinical Research Assoc., Inc. | LRX | Class II | 1995-05-16 |
| K951702 | FMS HIGH FLOW ARTHRO-SHEATH | Future Medical Systems, Inc. | HNX | Class I | 1995-05-12 |
| K943939 | NON-CONTACT TONOMETER T-2 | Canon, Inc. | HKX | Class II | 1995-05-12 |
| K951181 | RYDER CONTACT LENS CASE | Bradstreet Clinical Research Assoc., Inc. | LRX | Class II | 1995-05-12 |
| K951168 | CRYSTAL | Crystal Optical Co., Ltd. | HQY | Class I | 1995-05-12 |
| K951184 | OTI MODEL 78-60 | Oti Medical, LLC | HJO | Class II | 1995-05-12 |
| K951131 | SUNGLASSES, NONPRESCRIPTION | Gold, Inc. | HQY | Class I | 1995-05-10 |
| K951438 | BENSON AND ASHLEY | Benson & Ashley, Inc. | HQY | Class I | 1995-05-10 |
| K950600 | VACUUM SURGE SUPRESSER | Surgin Surgical Instrumentation, Inc. | HQC | Class II | 1995-05-10 |
| K951701 | FMS ARTHRO-CUTTER | Future Medical Systems, Inc. | HNX | Class I | 1995-05-09 |
| K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE | Rudolf Riester GmbH & Co. KG | HKY | Class II | 1995-05-08 |
| K950056 | THE GRIESHABER AXIAL CUTTER | Grieshaber & Co. | HKP | Class II | 1995-05-05 |
| K950520 | BURR, CORNEAL, BATTERY-POWERED | Aaron Medical Industries | HOG | Class I | 1995-05-02 |
| K951008 | POWER RANGERS SUNGLASSES | Siegel,Mandell & Davidson,P.C. | HQY | Class I | 1995-05-02 |
| K951504 | SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES | Sunnex Fashion Corp. | HQY | Class I | 1995-04-28 |
| K950799 | PRO-VIT | M. Imonti and Associates Inc., | HQE | Class II | 1995-04-28 |
| K940724 | NONE-GENERIC | Top Fashion Optical & Sunglasses | HQY | Class I | 1995-04-28 |
| K942142 | FRINDLEY ENTERPRISE CO | Frindley Enterprise Co., Ltd. | HQY | Class I | 1995-04-18 |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Surgical Technologies, Inc. | HQE | Class II | 1995-04-18 |
| K940725 | NONE-GENERIC | Yon'S Jay Enterprise Co. | HQY | Class I | 1995-04-18 |
| K951439 | SUNGLASSES | Long Train Enterprise Co., Ltd. | HQY | Class I | 1995-04-18 |
| K942374 | ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS | Sunsoft Corp. | LPL | Class II | 1995-04-13 |
| K951437 | OTI MODEL TLS-60 | Oti Medical, LLC | HPC | Class I | 1995-04-11 |
| K951340 | NEITZ SLIT LAMP SL-H1 | Neitz Instruments Company, Ltd. | HJO | Class II | 1995-04-10 |
| K950287 | UNIVIT PROBE | Medical Instrument Development Laboratories, Inc. | HKP | Class II | 1995-04-10 |
| K945761 | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP | Aaron Medical Industries | HQP | Class II | 1995-04-10 |
| K945808 | RUNNING SUNGLASSES | Million HU Corp. | HQY | Class I | 1995-04-10 |
| K950878 | MENICON SP VIAL | Hyman, Phelps & McNamara, P.C. | LRX | Class II | 1995-04-07 |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | Neitz Instruments Company, Ltd. | HLI | Class II | 1995-04-07 |
| K940848 | GELFLEX | Venture Management Corp. | LPL | Class II | 1995-04-07 |
| K951180 | ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Szabocsik and Assoc. | LPL | Class II | 1995-04-07 |
| K943178 | DELTA | Venture Management Corp. | LPL | Class II | 1995-04-07 |
| K950530 | PRO-TEC-CASE | Hyman, Phelps & McNamara, P.C. | LRX | Class II | 1995-04-07 |
| K951209 | SUNGLASSES | Mainland Wholesale | HQY | Class I | 1995-04-04 |
| K950461 | WELCH ALLYN OPHTHALMOSCOPE | Welch Allyn, Inc. | HLI | Class II | 1995-04-04 |
| K950792 | STREAK RETINOSCOPE RX-3A | Neitz Instruments Company, Ltd. | HKM | Class I | 1995-03-28 |
| K950795 | STREAK RETINOSCOPE RX-RP | Neitz Instruments Company, Ltd. | HKM | Class I | 1995-03-28 |
| K950793 | SPOT RETINOSCOPE RX-3SP | Neitz Instruments Company, Ltd. | HKM | Class I | 1995-03-28 |
| K950083 | MULTIPLE | Commonwealth Optical Manufactory , Ltd. | HQY | Class I | 1995-03-28 |
| K950791 | STREAK RETINOSCOPE RX-3 | Neitz Instruments Company, Ltd. | HKM | Class I | 1995-03-28 |
| K950789 | STREAK RETINOSCOPE RX-1 | Neitz Instruments Company, Ltd. | HKL | Class II | 1995-03-28 |
| K950794 | STREAK RETINOSCOPE RX-RC | Neitz Instruments Company, Ltd. | HKM | Class I | 1995-03-28 |
| K944313 | SPECTACLE FRAME | Sun Hing Optical Manufactory , Ltd. | HQZ | Class I | 1995-03-28 |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Neitz Instruments Company, Ltd. | HLJ | Class II | 1995-03-28 |
| K946227 | STORZ PREMIERE(R) MICROSURGICAL SYSTEM | Storz Instrument Co. | HQC | Class II | 1995-03-22 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.