meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
26
Latest Decision
1994-11-22

Clearances · page 25 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K941550 AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT Chiron Vision Corp. HNO Class I 1994-11-22
K945123 ARISTAR EYEWEAR, ESPRIT EYEWEAR Aristar Inc. U.S.A. HQZ Class I 1994-11-22
K941437 UNBREAKABLE LENS Nam Hing Plastic Factory , Ltd. HQY Class I 1994-11-22
K945036 BRIGHTEN New Daley Intl. Trading Co. HQY Class I 1994-11-22
K945122 ARISTAR EYEWEAR, ESPRIT EYEWEAR Aristar Inc. U.S.A. HQY Class I 1994-11-22
K945340 SPECTACLE FRAMES OR EYEGLASS FRAMES Mi Mun Corp. HQZ Class I 1994-11-22
K945450 FRAME, SPECTACLE Kookje Apis Industrial Co. HQZ Class I 1994-11-22
K944312 SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR Shelin International Ent., Inc. HQY Class I 1994-11-22
K945323 SPECTACLE FRAME M.Y. Vision Corp. HQZ Class I 1994-11-22
K944402 FOCOMETER Lacrimedics, Inc. HLJ Class II 1994-11-22
K944616 KERATRON CORNEAL TOPOGRAPHER Alliance Medical Marketinig HLQ Class I 1994-11-22
K945249 RED DRAGON CORPORATION J C Intl., Inc. HQY Class I 1994-11-22
K944996 NON-PRESCRIPTION SUNGLASSES La Kinglong Intl., Inc. HQY Class I 1994-11-22
K944022 LENSCHEK Leica, Inc. HLM Class I 1994-11-17
K944526 OPTICAL FRAMES AND SUNGLASSES Aprilia Eyewear S.P.A. HQY Class I 1994-11-15
K944644 SUNGLASSES AND SPECTACLE FRAMES Hung Wai Metal Manufactory HQY Class I 1994-11-15
K944341 ROYAL PLASTIC SUNGLASSES Royal Plastic Sarl HQY Class I 1994-11-14
K944641 NIL Max-Vision (H.K.)Limited HQZ Class I 1994-11-14
K943956 RETINA TOMOGRAPH AND FLOWMETER Heidelberg Engineering HLI Class II 1994-11-14
K944261 RETINA ANGIOGRAPH Heidelberg Engineering HLI Class II 1994-11-14
K943955 RETINA FLOWMETER Heidelberg Engineering HLI Class II 1994-11-14
K944484 KODI OPTICAL CO., LTD. SUNGLASSES Kodi Optical Co. , Ltd. HQY Class I 1994-11-10
K945001 SUNGLASSES Long Sheng Optical Co., Ltd. HQY Class I 1994-11-10
K931072 HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE Hgm, Inc. HJM Class II 1994-11-10
K933976 MANDELKORN SUTURE LYSIS LENS Ocular Instruments, Inc. HJK Class II 1994-11-08
K933264 RITCH NYLON SUTURE LASER LENS Ocular Instruments, Inc. HJK Class II 1994-10-31
K941883 CONTACT LENS Airperm, Inc. HQD Class II 1994-10-28
K944783 SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES Sun Eyewear Co. HQY Class I 1994-10-27
K944394 SUNGLASSES Unique Industries, Inc. HQY Class I 1994-10-27
K943784 MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR Menicon Co, Ltd. HQD Class II 1994-10-20
K931678 ORTHOMET LHMC FEMORAL STEM Orthomet, Inc. HMC Class II 1994-10-14
K941998 OCU-FLEX-38 (POLYMACON) Ocu-Ease Optical Products, Inc. LPL Class II 1994-10-13
K943672 PHACO NEEDLES AND TIPS Microsurgical Technology, Inc. HQC Class II 1994-10-13
K943379 PHACO TIPS FOR PHACO FRAGMENTATION MACHINES Oasis Medical, Inc. HQC Class II 1994-10-11
K943921 RYDER CONTACT LENS CASE Clinical Research Assoc. LRX Class II 1994-10-11
K944328 TONKA BOYS SUNGLASSES Hasbro Industries, Inc. HQY Class I 1994-10-03
K944281 SUNGLASSES Sun Glory Optic CO , Ltd. HQY Class I 1994-10-03
K942011 SUNGLASSES Shanghai Gopher Arts & Crafts Co., Ltd. HQY Class I 1994-10-03
K944722 PRECISION UV(TM) (VASURFILCON A) Pilkington Barnes-Hind, Ltd. LPL Class II 1994-10-03
K940997 AL-3300 Hoya Corp. USA HLM Class I 1994-09-29
K941865 XPERT NCT Reichert Ophthalmic Instruments, Div. Leica, Inc. HKX Class II 1994-09-29
K936200 WIRELESS CHART PROJECTOR,HCP-W 721 Canon USA, Inc. HOS Class I 1994-09-28
K944373 SPECTACLE FRAMES Custom Optical Frames, Inc. HQZ Class I 1994-09-28
K941006 SUNGLASSES Opti-Ray, Inc. HQY Class I 1994-09-28
K936205 COMPREHENSIVE PHOROPTER, MDR-680 Canon USA, Inc. HKN Class I 1994-09-28
K940083 STANDARD PHACO TIP 15, 30, 45, 60 Medical Technical Products HQC Class II 1994-09-28
K944160 SILHOUETTE, SUNLIMETED,ADIDAS Silhouette Optical , Ltd. HQZ Class I 1994-09-28
K936199 AUTOMATIC LENSOMETER Canon USA, Inc. HLM Class I 1994-09-28
K933445 DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) Storz Instrument Co. HJM Class II 1994-09-23
K943031 BIPOLAR ELECTROSURGICAL PENCIL Boston Surgical Products, Inc. HQO Class II 1994-09-23
K943613 NIL Sing Wah International Enterprises , Ltd. HOI Class I 1994-09-21
K940593 DISPOSABLE MICROSTAAR INJECTOR Staar Sugical KYB Class I 1994-09-19
K943561 SPECTACLE FRAME Australian Optical Co., Inc. HQZ Class I 1994-09-14
K943562 SUNGLASSES Australian Optical Co., Inc. HQY Class I 1994-09-14
K943641 SPECTACLE FRAME Australian Optical Co., Inc. HQZ Class I 1994-09-14
K943640 SUNGLASS CLIP Australian Optical Co., Inc. HQY Class I 1994-09-14
K944108 NIL Micron Metal & Plastic Manufactory Co. HQY Class I 1994-09-14
K944109 NIL Keep Top Intl., Ltd. HQY Class I 1994-09-14
K943963 NIL Max-Vision (H.K.)Limited HQY Class I 1994-09-14
K943792 SPECTACLE FRAMES Kt Optique, Inc. HQZ Class I 1994-09-14
K944026 MIRAGE EYEWEAR INC. Mirage Eyewear, Inc. HQY Class I 1994-09-14
K943296 ILO MADE IN ITALY; GARBO HAND FINISHED ITALY Ilo Industria Lombarda Ottica Srl HQY Class I 1994-09-14
K940421 SUNGLASSES Double Hero Corp. HQY Class I 1994-09-14
K942494 LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS Permeable Technologies, Inc. LPL Class II 1994-09-08
K943913 MAX FRAME DESIGN Noble Optic HQZ Class I 1994-09-07
K943840 (BRAND NAME0 MONDAIN Chan'S Plastic Manufactory Co., Ltd. HQY Class I 1994-09-06
K942322 SUNGLASSES Suntory Industrial Co. HQY Class I 1994-09-06
K943039 SPECTACLE FRAMES Rodenstock USA Inc., HQY Class I 1994-09-06
K940107 VIRECTOMY LENS Visionary Technologies of Miami, Inc. HJK Class II 1994-09-06
K943423 SPECTACLE FRAMES Galilee Optics HQZ Class I 1994-09-06
K943753 FRAME SPECTACLE Optic Tech Corp. HQZ Class I 1994-09-02
K940393 PEREGRINE WIDE ANGLE LIGHT PIPE Peregrine Surgical , Ltd. HJM Class II 1994-09-02
K943125 QUADRASPHERIC FUNDUS LENS Volk Optical, Inc. HJK Class II 1994-09-02
K943275 MEDPOR SURGICAL IMPLANT MATERIAL Porex Surgical, Inc. HPZ Class II 1994-09-02
K942242 AUTO REF-KERATOMETER, RK-3 Cannon U.S.A., Inc. HKO Class I 1994-09-02
K941726 SUNGLASSES Yowmost Enterprise Co., Ltd. HQY Class I 1994-09-02
K943677 SUNGLASSES Jenn Wei Glass Company, Ltd. HQY Class I 1994-08-29
K941420 50 DEGREE HRI PRISM LENS Ocular Instruments, Inc. HJK Class II 1994-08-29
K943912 SUNGLASSES Kason Enterprises Limited HQY Class I 1994-08-29
K925606 OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS Chiron Vision Corp. HMR Class I 1994-08-29
K931731 STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY Storz Instrument Co. HPL Class I 1994-08-29
K943177 BOSTON(R) 7 - 30(ENFLUFOCON A) Polymer Technology Corp. HQD Class II 1994-08-25
K940392 PEREGRINE PIC MINIPULATOR Peregrine Surgical , Ltd. KYG Class I 1994-08-23
K942531 SUNGLASSES Lumen S.R.L. HQY Class I 1994-08-23
K942403 INFUSION CANNULA Microsurgical Technology, Inc. HMX Class I 1994-08-17
K943405 STYLE I WRAPPER SUNGLASSES Plastic, Inc. HQY Class I 1994-08-17
K943377 SUNGLASSES (NON-PRESCRIPTION) Carol Wright Sales HQY Class I 1994-08-17
K940969 SUNGLASSES Tzong Rong Sunglasses Mfg. Co., Ltd. HQY Class I 1994-08-16
K943501 SUNGLASSES AND SPORT SUNGLASSES Sino-World Champion Co., Ltd. HQY Class I 1994-08-16
K943263 NIL Sing Wah International Enterprises , Ltd. HQY Class I 1994-08-15
K943568 FACONNABLE EYEWEAR (SUNGLASSES) Blink Designs, Inc. HQY Class I 1994-08-11
K943609 SUNGLASSES Konwan Optical Xiamen Co., Ltd. HQY Class I 1994-08-11
K943490 CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES Continental Soft Lens, Inc. LPL Class II 1994-08-11
K943326 SPECTACLE FRAMES Buffard-La-Doye HQZ Class I 1994-08-10
K935264 CHILDREN'S SUNGLASSES Agglo Corp. , Ltd. HQY Class I 1994-08-10
K943567 FACONNABLE EYEWEAR Blink Designs, Inc. HQZ Class I 1994-08-10
K942754 SUNGLASSES Kimball Corp. HQY Class I 1994-08-05
K942720 NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 Neitz Instruments Company, Ltd. HLI Class II 1994-08-05
K942719 NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR Neitz Instruments Company, Ltd. HLJ Class II 1994-08-05
K942711 NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 Neitz Instruments Company, Ltd. HLI Class II 1994-08-05

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