meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
18
Latest Decision
1996-03-28

Clearances · page 22 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960380 SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS Unilens Corp., USA LPL Class II 1996-03-28
K955901 STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX Storz Instrument Co. HQC Class II 1996-03-28
K954524 W-55 (METHAFILON A) CONTACT LENS Westcon Contact Lens Co., Inc. LPL Class II 1996-03-28
K955366 TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS Rand Scientific Corp. HQD Class II 1996-03-28
K960376 FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS Unilens Corp., USA LPL Class II 1996-03-28
K955900 NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR Novavision, Inc. HQD Class II 1996-03-25
K960291 TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS Ocu-Ease Optical Products, Inc. LPL Class II 1996-03-25
K955789 ALCON SERIES 20000 LEGACY MACKOOL SYSTEM Alcon Laboratories HQC Class II 1996-03-21
K960650 NON PRESCRIPTION SUN GLASSES Solovision Optical, Inc. HQY Class I 1996-03-19
K954124 O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS Optical Polymer Research, Inc. HQD Class II 1996-03-19
K960573 SUNGLASSES/EYEGLASS FRAMES Architectures HQY Class I 1996-03-12
K960797 D & K SUNGLASSES D&K Stores, Inc. HQY Class I 1996-03-12
K960786 FABRIS LAN SUNGLASSES Fabris Lane Intl., Ltd. HQY Class I 1996-03-12
K960261 PALLIKARIS BRUSH Alcon Laboratories, Inc. HOG Class I 1996-03-11
K960530 ARNET OR ARNETTE Arnet Optic Illusions HQY Class I 1996-03-04
K960628 LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE ZONE Lanard Toys, Ltd. HQY Class I 1996-03-04
K952151 STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) Storz HQR Class II 1996-03-04
K954816 STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX Storz Instrument Co. HQE Class II 1996-03-04
K955933 BUFFARD CREATION (SUNGLASSES) Buffard Creation Eurl HQY Class I 1996-03-04
K960289 JAMES KOREA OPTICAL FRAMES & SUNGLASSES James Korea Co., Ltd. HQY Class I 1996-02-16
K953807 DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS Stephen A. Dunn, Inc. LPL Class II 1996-02-14
K955245 MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM Mentor O & O, Inc. HQC Class II 1996-02-12
K955158 SURGITRON Ellman Intl., Inc. HQR Class II 1996-02-09
K955287 ZONG RONG SUNGLASSES Yuu Yeng Enterprise Co., Ltd. HQY Class I 1996-01-29
K955441 ZONG RONG SUNGLASSES Zong Rong Glasses Ltd. Co. HQY Class I 1996-01-29
K955695 PLASTIC FRAME, METAL FRAME, OPTICAL Dah Sing Trading Co. HQY Class I 1996-01-29
K954939 MEDPOR OCULAR SCREW & ACCESSORIES Porex Surgical, Inc. HPZ Class II 1996-01-25
K954746 PHACO TIP U.S. Iol, Inc. HQC Class II 1996-01-11
K954659 MOONSHADES SUNGLASSES Blublocker Corp. HQY Class I 1996-01-11
K955572 SUNGLASSES WITH IMPACT RESISTANT LENSES Diamond Mark International Co., Ltd. HQY Class I 1996-01-11
K952569 GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR Gamp & Assoc. HQR Class II 1996-01-05
K954603 DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT Wesley Jessen Corp. LPL Class II 1996-01-04
K955539 UNISUN Steven Chen HQY Class I 1996-01-03
K952260 OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) Stellar Contact Lens, Inc. HQD Class II 1996-01-03
K955442 KOWA SC-1200 PHOTO SLIT LAMP SYSTEM Kowa Optimed, Inc. HKI Class II 1996-01-03
K955611 KMANZ II Gatorz LLC HQY Class I 1996-01-03
K953539 DM001 DISPOSABLE PACK American Optisurgical, Inc. HQC Class II 1995-12-26
K953538 RM001 REUSABLE American Optisurgical, Inc. HQC Class II 1995-12-26
K954308 GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE Gamp & Assoc. HQB Class II 1995-12-22
K954307 GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE Gamp & Assoc. HQB Class II 1995-12-22
K954306 GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE Gamp & Assoc. HQB Class II 1995-12-22
K954600 MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) Staar Surgical Co. KYB Class I 1995-12-21
K954340 STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE Storz HQC Class II 1995-12-14
K955127 HANYANG SUNGLASSES Hanyang Industries, Inc. HQY Class I 1995-12-14
K953199 METRO 55G TORIC & SPHERICAL Metrosoft, Inc. LPL Class II 1995-12-11
K954238 SURGIN GENISIS HANDPIECE Surgin Surgical Instrumentation, Inc. HQC Class II 1995-12-08
K954239 U.S. IOL PHACO HANDPIECE U.S. Iol, Inc. HQC Class II 1995-12-08
K954237 CIRCUIT TREE PHACO HANDPIECE Circuit Tree HQC Class II 1995-12-08
K955290 KUO & YANG SUNGLASSES Kuo & Yang Industrial Co., Ltd. HQY Class I 1995-12-06
K954781 KOWA GENESIS HAND-HELD FUNDUS CAMERA Kowa Optimed, Inc. HKI Class II 1995-12-01
K954240 EVOLUTION PHACOMULSIFIER U.S. Iol, Inc. HQC Class II 1995-12-01
K952620 OPTICAL BLANKS: BENZ55G CLEAR AND VISIBILITY TINTED Benz Research and Development Corp. LPL Class II 1995-12-01
K954241 SURGIN GENISIS PHACOEMULSIFIER Surgeon Surgical Instrumentation, Inc. HQC Class II 1995-12-01
K954780 KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C Kowa Optimed, Inc. HKI Class II 1995-12-01
K954242 CIRCUIT TREE PHACOEMULSIFIER Circuit Tree HQC Class II 1995-12-01
K954782 KOWA PORTABLE SLIT LAMP SL-14 & SL-14B Kowa Optimed, Inc. HJO Class II 1995-11-24
K954167 HUMPHREY FIELD ANALYZER (HFA II) Carl Zeiss, Inc. HPT Class I 1995-11-24
K954139 AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS CooperVision, Inc. LPL Class II 1995-11-24
K953973 ANGIOVISION 1000 Medivision Medical Imaging, Ltd. HKI Class II 1995-11-17
K953959 PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES Microsurgical Technology, Inc. HQC Class II 1995-11-17
K953972 ANGIOVISION VIEWING STATION Medivision Medical Imaging, Ltd. HKI Class II 1995-11-17
K951893 LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS Permeable Technologies, Inc. LPL Class II 1995-11-17
K954037 FIELD TREND Synemed, Inc. HPT Class I 1995-11-17
K954058 BARRAQUER-KRUMEICH REFRACTIVE SET Eyetech M.V.A. HNO Class I 1995-11-06
K950869 JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE Jobar Intl., Inc. LRX Class II 1995-10-27
K951463 STORZ I/A HANDPIECES Storz Instrument Co. HQC Class II 1995-10-27
K953744 AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES Amita Corp. HQY Class I 1995-10-25
K954636 BLINDE OPTICS Blinde Eyewear, Inc. HQY Class I 1995-10-25
K953808 CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES Cheng Chen Hsing Enterp. & Fact. Co. , Ltd. HQY Class I 1995-10-25
K954393 SINCLAIR NON-PRESCRIPTION SUNGLASSES Sinclair Corp. HQY Class I 1995-10-25
K953627 NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES New Sun Optical Enterprise Co., Ltd. HQY Class I 1995-10-25
K954639 SUNGLASSES Walmart Stores HQY Class I 1995-10-25
K951757 DRIVING GLASSES Proview Optical Group Corp. HQY Class I 1995-10-25
K945445 BOBES SLIT LAMP Bobes S.A. HJO Class II 1995-10-17
K953359 TRI-STAR UNIVERSAL I/A PHACO PAK Tri-Star Ophthalmic HQC Class II 1995-10-17
K953447 PRECISIONIST THIRTY THOUSAND Paradigm Medical Industries, Inc. HQC Class II 1995-10-13
K944993 IOLAB.SITE CD PHACOEMULSIFICATION MODULE Chiron Vision Corp. HQC Class II 1995-10-12
K944995 IOLAB/SITE PERISTALTIC MODULE Chiron Vision Corp. HQC Class II 1995-10-05
K954173 SPECTACLE SUN GLASSES (NON PRESCRIPTION) Monte Carlo Eyewear, Inc. HQY Class I 1995-10-03
K953965 904 SLIT LAMP Clement Clarke, Inc. HJO Class II 1995-09-27
K953804 VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS Vistakon, Johnson & Johnson Vision Products, Inc. LPL Class II 1995-09-26
K951079 NIDEK MODEL GYC-1500 AND GYC-2000 Nidek, Inc. HQF Class II 1995-09-14
K953575 STORZ MVS-3201 VITRECTOMY PROBE PACK Storz Instrument Co. HQE Class II 1995-09-14
K953576 STORZ DP4505 VITREOUS MEMBRANE DISSECTOR Storz Instrument Co. HQE Class II 1995-09-14
K954075 YEOU NAN SUNGLASSES FRAME MFG, CO., LTD. Yo Nan Sunglasses Co., Ltd. HQY Class I 1995-09-12
K953920 REVERT SUNGLASSES & POLAR SUNGLASSES Bella Occhiali, Inc. HQY Class I 1995-09-12
K953782 NIL Dehang Industries, Ltd. HQY Class I 1995-09-12
K952438 SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) Taiwan Eva Industrial Co., Inc. HQY Class I 1995-09-12
K953947 SUNGLASSES Wenzhou Yian Optical International, Co., Ltd. HQY Class I 1995-09-12
K952597 VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW Point of View Optical Outlet, Inc. HQZ Class I 1995-09-12
K952963 SUNGLASSES & SPORT SUNGLASSES Wenzhou Winsor Optical International Co., Ltd. HQY Class I 1995-09-12
K953989 SUNGLASSES Morris & Sons Co. HQY Class I 1995-09-12
K950881 PHACO TIP American Optical Corp. HQC Class II 1995-09-06
K952480 ORIMS DIGITAL ANGIOGRAPHY SYSTEM Midwest Ophthalmic Instruments, Inc. HKI Class II 1995-08-25
K952468 HI-LINE MEDICAL PHACOEMULSIFIER TIP Hi-Line Medical HQC Class II 1995-08-24
K953629 SPECTACLE SUNGLASSES(NON-PRESCRIPTION) Lowinger Holdings, Inc. HQY Class I 1995-08-23
K953031 ZEIMER SELF TONOMETER Cds Technologies HKX Class II 1995-08-22
K945972 DIGITAL AVERAGING TONOMETER Opti-Med Electronics HKX Class II 1995-08-17
K952331 AOI LC-40 PHACOEMULSIFIER American Optisurgical, Inc. HQC Class II 1995-08-16
K952894 VISULINK 900 ARGON Carl Zeiss, Inc. HQF Class II 1995-08-14

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