Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 21
- Latest Decision
- 1996-11-25
Clearances · page 21 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K964082 | SUNGLASSES | Neo Vu, Inc. | HQY | Class I | 1996-11-25 |
| K963010 | LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Permeable Technologies, Inc. | HQD | Class II | 1996-11-20 |
| K961606 | METRO FOCAL ASPHERIC (POLYMACON) | Metro Optics of Austin, Inc. | LPL | Class II | 1996-11-20 |
| K963488 | SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED) | Specialty Ultravision, Inc. | LPL | Class II | 1996-11-20 |
| K963968 | FLYWAY | Look Style, S.R.L. | HQY | Class I | 1996-11-19 |
| K963955 | DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS | Bert & Joe'S, Inc. | HQY | Class I | 1996-11-19 |
| K963890 | VARIOUS SUNGLASSES (NON-PRESCRIPTION) | Italian Eyewear, Inc. | HQY | Class I | 1996-11-19 |
| K960287 | HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM | Nidek, Inc. | HQC | Class II | 1996-11-05 |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Fci Ophthalmics, Inc. | HQX | Class II | 1996-10-28 |
| K963333 | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) | Karl Storz Imaging, Inc. | HKI | Class II | 1996-10-22 |
| K963630 | C.O.L.D.A. | C.O.L.D.A. S.N.C. | HQY | Class I | 1996-10-18 |
| K962006 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | HQD | Class II | 1996-10-09 |
| K960811 | PHACOSCOPE | Saint John'S Plaza Medical Group | HQC | Class II | 1996-10-02 |
| K962957 | RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT | Wesley Jessen Corp. | LPL | Class II | 1996-10-01 |
| K962000 | FLEXLENS(METHAFILCON A) | Flexlens, Inc. | LPL | Class II | 1996-10-01 |
| K962804 | ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER | Vistakon, Johnson & Johnson Vision Products, Inc. | LPL | Class II | 1996-10-01 |
| K961299 | PRECISION UV (VASURFILCON A) | Pilkington Barnes-Hind, Ltd. | LPL | Class II | 1996-10-01 |
| K961943 | FLEXLENS | Flexlens, Inc. | LPL | Class II | 1996-10-01 |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Storz Instrument Co. | HQC | Class II | 1996-09-20 |
| K962402 | AMO PRESTIGE DAY PACK (ALLERGAN, INC.) | Allergan, Inc. | HQC | Class II | 1996-09-19 |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Storz Instrument Co. | HQE | Class II | 1996-09-18 |
| K962711 | GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS | Gelflex Laboratories | LPL | Class II | 1996-09-05 |
| K962710 | GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | Gelflex Laboratories | LPL | Class II | 1996-09-05 |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | Dutch Ophthalmic USA, Inc. | HQO | Class II | 1996-08-29 |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Storz Instrument Co. | HQC | Class II | 1996-08-29 |
| K960971 | OCULIGHT GL | Iriderm Div. | HQF | Class II | 1996-08-28 |
| K962934 | AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR | Airperm, Inc. | HQD | Class II | 1996-08-27 |
| K963284 | RAVEN EYE- EYE WEAR (SUNGLASSES) | Raven Eye, Inc. | HQY | Class I | 1996-08-26 |
| K962279 | ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES | Jane Fui Optical Co., Ltd. | HQY | Class I | 1996-08-26 |
| K962940 | RAVEN EYE, INC.- EYE WEAR | Raven Eye, Inc. | HQY | Class I | 1996-08-26 |
| K963083 | LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES | Piazza Optical Corp. | HQY | Class I | 1996-08-26 |
| K962121 | HORIZON/WESTHIN 55-G | Westcon Contact Lens Co., Inc. | LPL | Class II | 1996-08-26 |
| K960767 | LIGHT COMMANDER | Scieran Technologies, Inc. | FCT | Class II | 1996-08-26 |
| K963059 | SUNQUEST INTERNATIONAL | Sunquest Intl., Inc. | HQY | Class I | 1996-08-23 |
| K961103 | BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT | Benz Research and Development Corp. | LPL | Class II | 1996-08-23 |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | Storz Instrument Co. | HQC | Class II | 1996-08-23 |
| K962241 | GORE SPHEREX IMPLANT | W. L. Gore & Associates, Inc. | HPZ | Class II | 1996-08-22 |
| K963075 | FITO DIDO | Framesmart, Inc. | HQY | Class I | 1996-08-22 |
| K962912 | MARCELLA CARAN | Framesmart, Inc. | HQY | Class I | 1996-08-22 |
| K960584 | NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY | Novavision, Inc. | HQD | Class II | 1996-08-15 |
| K962287 | EAGLE EYES SUNGLASSES | Positive Response Television | HQY | Class I | 1996-08-14 |
| K961831 | STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK | Storz Instrument Co. | HQC | Class II | 1996-08-06 |
| K961874 | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK | Storz Instrument Co. | HQC | Class II | 1996-08-06 |
| K962532 | RODENSTOCK SLITLAMP (MODEL 5000 & 4000) | Expertech Assoc., Inc. | HJO | Class II | 1996-07-25 |
| K962298 | CENTER OPTICAL GLASSES | Mirage Eyewear, Inc. | HQY | Class I | 1996-07-25 |
| K962775 | SUNGLASSES (NON-PRESCRIPTION) | Canadd Trading Co. | HQY | Class I | 1996-07-25 |
| K962522 | MODEL SL-YZ5E | Pacific Ophthalmic Supply | HJO | Class II | 1996-07-25 |
| K962636 | SUNGLASSES, GAUDI SUN LINE | Gaudi Spa | HQY | Class I | 1996-07-25 |
| K961820 | STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK | Storz Instrument Co. | HQC | Class II | 1996-07-25 |
| K962478 | (BRAND NAME) SUNGLASS FRAMES | Custom Optical Frames, Inc. | HQY | Class I | 1996-07-25 |
| K962725 | SOMA | Soma International , Ltd. | HQY | Class I | 1996-07-25 |
| K962382 | XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. | Xiamen Chingsong Optical Industrial Co., Ltd. | HQY | Class I | 1996-07-25 |
| K962431 | CTM DISPOSABLE PAK | Circuit Tree Medical, Inc. | HQC | Class II | 1996-07-23 |
| K962430 | CTM REUSABLE PAK | Circuit Tree Medical, Inc. | HQC | Class II | 1996-07-23 |
| K961658 | MEGATRON OPHTHALMIC SURGICAL SYSTEM | Intl. Ophthalmic Industries Corp. | HQC | Class II | 1996-07-23 |
| K960522 | DIOPEXY PROBE | Iriderm Div. | HQF | Class II | 1996-07-19 |
| K961512 | PERKINS HAND-HELD APPLANATION TONOMETER | Clement Clarke, Inc. | HKY | Class II | 1996-07-18 |
| K962512 | BOSTON CONTACT LENS CASE | Polymer Technology Div. Wilmington Partners, L.P. | LRX | Class II | 1996-07-12 |
| K961243 | OCUSYSTEM ART ADVANTAGE | Surgical Design Corp. | HQC | Class II | 1996-07-10 |
| K962310 | NON-GENERIC | Classic Elegance Intl., Inc. | HQY | Class I | 1996-07-03 |
| K962412 | NIKE V8 AND NIKE V12 | Nike, Inc. | HQY | Class I | 1996-07-03 |
| K962436 | SUNGLASSES | Chungsin Kau Optical Mfy. Co. , Ltd. | HQY | Class I | 1996-07-02 |
| K961310 | STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES) | Storz Instrument Co. | HQC | Class II | 1996-06-27 |
| K962169 | MAGNETO EYEWEAR | Nike, Inc. | HQY | Class I | 1996-06-24 |
| K961171 | HUMPHREY OCT SCANNER | Carl Zeiss, Inc. | HLI | Class II | 1996-06-21 |
| K962107 | IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 | Leonachi, Inc. | HQY | Class I | 1996-06-20 |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | Kowa Optimed, Inc. | HPT | Class I | 1996-06-17 |
| K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM | Allergan, Inc. | KYB | Class I | 1996-06-17 |
| K961078 | AUTOMATED VITRECTOMY DEVICE | Promex, Inc. | HQE | Class II | 1996-06-14 |
| K961990 | NON-PRESCRIPTION SUNGLASSES | Rokko Stars Co., Ltd. | HQY | Class I | 1996-06-06 |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | HQX | Class II | 1996-06-05 |
| K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | Kowa Optimed, Inc. | HKY | Class II | 1996-06-04 |
| K960818 | SUNGLASSES | Visard Srl | HQY | Class I | 1996-05-31 |
| K960668 | MISTRAL SUNGLASSES | Mistral Optical | HQY | Class I | 1996-05-31 |
| K960953 | SUNGLASSES | Galilee Optics | HQY | Class I | 1996-05-31 |
| K961146 | SUNGLASSES | Erica Optical Co. | HQY | Class I | 1996-05-31 |
| K960859 | MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES | Porex Technologies Corp. of Georgia | HPZ | Class II | 1996-05-29 |
| K961428 | SOFT-55 DAILY WEAR CONTACT LENS | Lombart Lenses, Ltd. | LPL | Class II | 1996-05-21 |
| K961746 | CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY | Eurotrends Eyewear, Inc. | HQY | Class I | 1996-05-16 |
| K961524 | STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS | Sterilab, Inc. | HNY | Class I | 1996-05-16 |
| K961286 | STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES | Intl. Optical Mfg. Co., Ltd. | HQY | Class I | 1996-05-16 |
| K954419 | SPECTACLE FRAMES/SUNGLASSES | Ami Fashion | HQY | Class I | 1996-05-16 |
| K960735 | EVERGLORY SUNGLASSES | Everglory Creations, Inc. | HQY | Class I | 1996-05-13 |
| K961523 | TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES | Dorda Toys | HQY | Class I | 1996-05-13 |
| K961603 | SUN CLIP | Intromark, Inc. | HQY | Class I | 1996-05-13 |
| K943145 | AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE | The Monticello Group, Inc. | HQY | Class I | 1996-04-29 |
| K960395 | PLANCON MIRCOLAMELLAR KERATOME | Plancon Instruments | HNO | Class I | 1996-04-26 |
| K960414 | SYNERGIST POWER PACK | Chiron Vision Corp. | HQC | Class II | 1996-04-24 |
| K961034 | SUNGLASSES | Kylie Enterprise Co. , Ltd. | HQY | Class I | 1996-04-24 |
| K961128 | SUNGLASSES | Vision-Pro Industrial, Ltd. | HQY | Class I | 1996-04-24 |
| K961268 | OAKLEY, INC SUNGLASSES | Oakley, Inc. | HQY | Class I | 1996-04-24 |
| K960798 | D & K SUNGLASSES | D&K Stores, Inc. | HQY | Class I | 1996-04-24 |
| K961117 | VISARD SUNGLASSES | Visard Srl | HQY | Class I | 1996-04-24 |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | Dutch Ophthalmic USA, Inc. | KYG | Class I | 1996-04-15 |
| K950294 | FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS | Flexlens, Inc. | LPL | Class II | 1996-04-11 |
| K961035 | US-HOLO SUNGLASSES | Mi Technologies, Inc. | HQY | Class I | 1996-04-10 |
| K960950 | FRANCO SORDELLI SUNGLASSES | Franco Sordelli & C. Snc | HQY | Class I | 1996-04-10 |
| K960890 | SUNGLASSES OR MULTIPLE | Outdoor Action Wear Specialties | HQY | Class I | 1996-04-10 |
| K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Unilens Corp., USA | LPL | Class II | 1996-04-10 |
| K953277 | SHADOW MEDAL LOCATOR | Fatswith Intl., Inc. | HPM | Class II | 1996-04-01 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.