meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
29
Latest Decision
1995-03-22

Clearances · page 24 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K950790 STREAK RETINOSCOPE RX-2 Neitz Instruments Company, Ltd. HKL Class II 1995-03-22
K951054 XCEL SLIT LAMP Leica, Inc. HJO Class II 1995-03-22
K951080 SUNGLASSES Taiwan Georgia Corp. HQY Class I 1995-03-22
K946226 CUSTOM OCULAR PROSTHESIS Frank Tanaka, Ocularist, Inc. HQH Class I 1995-03-22
K950922 CHAMP INTERNATIONAL CORP. Champ International Corp. HQY Class I 1995-03-22
K946016 IVALON OPHTHALMIC SPONGE Ivalon HOZ Class II 1995-03-22
K950796 HALOGEN DIAGNOSTIC SET BX A - 12345 Neitz Instruments Company, Ltd. HLJ Class II 1995-03-22
K950818 HORIZON 55 BI-CON TORIC Westcon Contact Lens Co., Inc. LPL Class II 1995-03-21
K944994 IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE Chiron Vision Corp. HQC Class II 1995-03-14
K946181 INFINITECH SOFT TIP FLUTE NEEDLE Surgical Technologies, Inc. HQE Class II 1995-03-14
K950938 HILTON, BENTLY SET, SENATOR, MAYFAIR MATCH AND MONSIUR Rahddim, Inc. HQY Class I 1995-03-14
K945922 NON-PRESCRIPTION SUNGLASSES Csi Industries, Inc. HQY Class I 1995-03-03
K945895 METAL FRAME, PLASTIC FRAME Sun Vista Intl., Inc. HQY Class I 1995-03-02
K950609 ORVIS KEY WEST SUNGLASSES The Orvis Co., Inc. HQY Class I 1995-03-02
K950519 SILHOUETTE SUNLIMITED ADIDAS Silhouette Optical , Ltd. HQY Class I 1995-03-02
K945877 WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT Wells Johnson Co. HJM Class II 1995-03-02
K950526 SUNGLASSES Tony Optical Enterprises Co., Ltd. HQY Class I 1995-03-02
K950599 STORS SCLERAL SPONGE II (LINCOFF DESIGN) Storz Ophthalmics, Inc. HQX Class II 1995-03-02
K950226 CHILDREN'S SUNGLASSES Consolidated Stores Corp. HQY Class I 1995-03-01
K950391 NON-PRESCRIPTION SUNGLASSES Aceway Sunglasses Corp. HQY Class I 1995-03-01
K945959 VIDEO VISION ANALYZER (VIVA), VRB 100 Tomey Corporation USA HKO Class I 1995-03-01
K950091 KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 Konan Medical, Inc. HKI Class II 1995-03-01
K950720 KBTC Kyong-Buk Trading Corp. HQY Class I 1995-03-01
K950456 MARTIN SUNGLASSES Jack Martin Co., Inc. HQY Class I 1995-03-01
K946194 WEE BAG O'MERCURY Microsurgical Technology, Inc. LCC Class II 1995-02-27
K950374 FOSSIL PARTNERS, L.P. (FOSSIL) Strasburger & Price, L.L.P. HQY Class I 1995-02-27
K950252 CHAMPRO/UNITED ATHLETIC Wilson Hunt Intl./, Ltd. HQY Class I 1995-02-27
K950241 OPHTHALMIC SPONGES Oasis Medical, Inc. HOZ Class II 1995-02-27
K950193 PHILIPPE CHARRIOL Philippe Charriol Dist., Inc. HQY Class I 1995-02-24
K942020 SUNGLASSES Hopper Radio Corp. HQY Class I 1995-02-24
K945114 VISITEC SCLERAL PLUG Visitec Co. LXP Class II 1995-02-23
K946381 SUNGLASSES Ialin Optical Mfg., (H.K.) Co. , Ltd. HQY Class I 1995-02-22
K941266 NON-PRESCRIPTION SUNGLASSES Gbs Corp. HQY Class I 1995-02-17
K941267 NON-PRESCRIPTION SUNGLASSES Topstar Trading , Ltd. HQY Class I 1995-02-17
K941717 MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT Miguel Martinez M.D. HPZ Class II 1995-02-14
K946176 STORZ PHACOEMULSIFICATION NEEDLES Storz Instrument Co. HQC Class II 1995-02-14
K945583 OCUSYSTEM(ART) Arent Fox HQC Class II 1995-02-13
K945171 DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE Boston Surgical Products, Inc. KYG Class I 1995-02-08
K950283 LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS Permeable Technologies, Inc. LPL Class II 1995-02-07
K945763 LOW TEMPERATURE CAUTERY ELONGATED FINE TIP Aaron Medical Industries HQP Class II 1995-02-07
K945680 METZLER, ALPINA, MENRAD, POLICE, L. BIAGIOTTI, CFF, R. LAUREN, POLO, NEOMETAL, L'AMY, NEOSTYLE ETC. Solex Marketing, Inc. HQY Class I 1995-02-07
K950079 SUNGLASSES Gianni Versace HQY Class I 1995-02-07
K945955 ROSE K LENS Rose K International , Ltd. HQD Class II 1995-02-07
K945981 LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS Permeable Technologies, Inc. LPL Class II 1995-02-07
K930628 KLAAS IOL LENSFOLDER Bova Intl. KYB Class I 1995-02-07
K945762 LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE Aaron Medical Industries HQP Class II 1995-02-07
K946058 60 FUNDUS CAMERA CF-60UV Canon USA, Inc. HKI Class II 1995-02-03
K945528 SUNGLASSES AND SPORT SUNGLASSES Lily & Assoicates, Inc. HQY Class I 1995-02-01
K946004 FI, GORDY TOY, WELLJOY AND OTHERS Fundamental Industrial Co., Ltd. HQY Class I 1995-01-31
K946092 AVON SUNNY DAYS SUNGLASSES Siegel,Mandell & Davidson,P.C. HQY Class I 1995-01-31
K945382 TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER Expertech Assoc., Inc. HLQ Class I 1995-01-31
K946091 AVON SUNNY DAYS SUNGLASSES Siegel,Mandell & Davidson,P.C. HQY Class I 1995-01-31
K945493 OPHTHALMIC CAUTERY Aaron Medical Industries HQP Class II 1995-01-30
K945259 DATEMINDER CONTACT LENS CASE Bruce A. Berkley LRX Class II 1995-01-24
K946012 PRECISION UV(TM) (VASURFICON A) Pilkington Barnes-Hind, Ltd. LPL Class II 1995-01-24
K943932 STERISEAL OPHTHALMIC CANNULA Pharma-Plast, Ltd. HMX Class I 1995-01-18
K945172 VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS Visitec Co. HQX Class II 1995-01-17
K946256 SUNGLASSES Chanel, Inc. HQY Class I 1995-01-17
K945925 EYEWEAR/SPECTACLES Kovision Mfg., Ltd. HQY Class I 1995-01-17
K945640 RI-SCOPE S OTOSCOPE Rudolf Riester GmbH & Co. KG HLJ Class II 1995-01-17
K946132 PROWAY Union Industrial Co., Ltd. HQY Class I 1995-01-17
K945920 SUNGLASSES Glendale Protective Technologies, Inc. HQY Class I 1995-01-17
K946231 EYE COOLER Direct Import Marketing Co. HQY Class I 1995-01-17
K945110 KOLBERG OPHTHALMIC CONFORMER Kolberg Ocular Products, Inc. HQN Class II 1995-01-13
K945988 SUNGLASSES R.J. Standard Corp. HQY Class I 1995-01-12
K944156 HEINE LAMBDA 100 Heine USA , Ltd. HOX Class I 1995-01-12
K945917 POWERR RANGERS SUNGLASSES Dollar Land Stores, Inc. HQY Class I 1995-01-12
K945823 POWER RANGERS SUNGLASSES Avon Products, Inc. HQY Class I 1995-01-09
K944568 SUNGLASSES Great Field Industries Co., Ltd. HQY Class I 1995-01-09
K945817 SUNGLASSES Walmart Stores HQY Class I 1995-01-05
K945683 VETTA LIGHTWEIGHT CYCLING EYEWEAR Shaw, Pittman, Potts & Trowbridge HQY Class I 1995-01-05
K945818 SUNGLASSES Walmart Stores HQY Class I 1995-01-05
K945819 SUNGLASSES Walmart Stores HQY Class I 1995-01-05
K945147 PECTACLE FRAMES AND/OR SUNGLASSES Mi MI Progress Co. , Ltd. HQY Class I 1995-01-05
K945735 SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSES Shu Gie Industrial Co., Ltd. HQY Class I 1995-01-05
K945840 BUNNY SUNGLASSES Tony (U.S.A.), Inc. HQY Class I 1995-01-05
K945365 HORIZON 55 BI-CON Westcon Contact Lens Co., Inc. LPL Class II 1994-12-28
K944700 ARCTIC PREMIER SERIES Sungold Eyewear, Inc. HOY Class I 1994-12-22
K944895 BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS Bausch & Lomb, Inc. LPL Class II 1994-12-19
K945770 OPTICAL FRAMES Ramada Optics, Inc. HQZ Class I 1994-12-15
K944857 GOGGLE SAFEGUARD Sellstrom Mfg. Co. HOY Class I 1994-12-15
K945176 SPECTACLE FRAME OR EYEGLASS FRAMES Optipia Trading Co. HQZ Class I 1994-12-15
K945392 SPECTACLE FRAME Seo Han Corp., Ltd. HQZ Class I 1994-12-15
K944398 SUNGLASSES Sun Island Enterprise Co., Ltd. HQY Class I 1994-12-15
K944235 ADVANCE CORP. SUNGLASSES Advance Corp. HQY Class I 1994-12-15
K945351 SHIELD, EYE, OPHTHALMIC Taiwan Eva Industrial Co., Inc. HOY Class I 1994-12-13
K945350 FRAME, SPECTACLES Taiwan Eva Industrial Co., Inc. HQZ Class I 1994-12-13
K944207 TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 Computed Anatomy, Inc. HLQ Class I 1994-12-07
K924277 DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING Chalgren Enterprises, Inc. HLT Class II 1994-12-07
K945341 MULTIPLE Mi MI Progress Co. , Ltd. HQY Class I 1994-12-07
K944223 ACCUCON Innovision, Inc. HQD Class II 1994-12-07
K945282 MULTIPLE Mi MI Progress Co. , Ltd. HQY Class I 1994-12-07
K945006 COLLEGIATE COLORS Trey Optics HQY Class I 1994-12-05
K942945 CASSETTE SYSTEM FOR STORZ Surgin Surgical Instrumentation, Inc. HQC Class II 1994-12-05
K935926 STORZ PHACO AND FRAG HANDPIECES Storz Instrument Co. HQC Class II 1994-11-28
K945342 MAG-1 SPECTACLE FRAME Criss Optical Mfg. Co., Inc. HQZ Class I 1994-11-28
K944915 AXIOM, SUNFAST Axiom Ent. Co., Ltd. HQY Class I 1994-11-22
K945346 MAKROLON 2405 GOGGLES (LIGHT AND DARK) Universal Massage & Tanning, Inc. HOY Class I 1994-11-22
K944910 TOMEY EM-1000 SPECULAR MICROSCOPE Tomey Corporation USA HJO Class II 1994-11-22
K942180 KEELER MULTILASE 3000 Keeler Instruments, Inc. HQF Class II 1994-11-22

4,756 clearances in the Ophthalmic panel. Data: openFDA.