meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
25
Latest Decision
1994-04-12

Clearances · page 28 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K940846 NIL Evergreat Optical Ind Co., Ltd. HQY Class I 1994-04-12
K941076 SUNGLASSES AND SPORT SUNGLASSES 20/20 Ent. HQY Class I 1994-04-12
K941059 FRONTIER NOVELTY DAELIM OPTICAL FRAME Frontier Novelty, Inc. HQZ Class I 1994-04-12
K940827 REWINNER ENT H.K. BRANCH NON-PRESCRIPTION SUNGLASSES Rainbow Merchandise, Inc. HQY Class I 1994-04-12
K940730 YON'S JAY ENTERPRISE CO Yon'S Jay Enterprise Co. HQY Class I 1994-04-12
K941052 EYEGLASS SPECTACLE FRAMES VARIOUS COLLECTIONS Atlantic Optical Co., Inc. HQZ Class I 1994-04-12
K941051 SPECTACLE FRAMES/SUNGLASSES Europa/Encore Eyewear HQY Class I 1994-04-12
K940613 E.M.A. European Manufacturers Agency, Inc. HQY Class I 1994-04-12
K940411 EYEGLASS FRAMES (PLASTIC) Value Line Optical Services, Inc. HQZ Class I 1994-04-11
K940956 RIO EYEWEAR, PANAMA JACK ENVIRONMENT OPTICS, AND PARADISE RESORT EYEWEAR Rio Eyewear Group, Inc. HQY Class I 1994-04-11
K940726 NONE-GENERIC Jay-Y Enterprises Co., Inc. HQY Class I 1994-04-11
K934407 SUNGLASS GALLERY INC. SUNGLASS Sunglass Gallery, Inc. HQY Class I 1994-04-11
K940830 REWINNER ENT CO. LTD. NON-PRESCRIPTION SUNGLASSES Rainbow Merchandise, Inc. HQY Class I 1994-04-11
K940828 WENZHOU IMPORT/EXPORT CORP. NON-PRESCRIPT SUNGLASSES Rainbow Merchandise, Inc. HQY Class I 1994-04-11
K940944 DAY SUN INDUSTRIAL CORP Day Sun Industrial Corp. HQY Class I 1994-04-11
K940612 E.M.A. European Manufacturers Agency, Inc. HQY Class I 1994-04-11
K940806 NON-PRESCRIPTION SUNGLASSES Top Fashion Optical & Sunglasses HQY Class I 1994-04-11
K930320 AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR Allergan Medical Optics KYB Class I 1994-04-07
K940326 SPECTACLE FRAME D'Tochi, Inc. HQZ Class I 1994-04-06
K932612 DAELIM CORP. EYE WEAR MODEL Daelim Corp. HQZ Class I 1994-04-06
K934461 NON-PRESCRIPTION SUNGLASSES Good Bond Industrial Corp. HQY Class I 1994-04-06
K935734 SUNGLASSES Esparkle International Co., Ltd. HQY Class I 1994-04-06
K935700 JIN CHANG SUNGLASSES Jin Chang Enterprise Co., Ltd. HQY Class I 1994-04-06
K935845 SPECTACLE FRAMES New Star Corp. HQZ Class I 1994-04-06
K934880 MTI PHOTOSCREENER Medical Technology and Innovations, Inc. MMF Class II 1994-04-06
K923630 PHACO NEEDLES 1000-R & 1000-O NEEDLES O.R. Specialties, Inc. HQC Class II 1994-04-06
K940560 SPECTACLE FRAMES Optical Xpressions, Ltd. HQZ Class I 1994-04-06
K935974 SPECTACLE FRAMES AND SUNGLASSES Pan Oceanic Eyewear HQY Class I 1994-04-06
K940614 E.M.A. European Manufacturers Agency, Inc. HQZ Class I 1994-04-06
K940420 TALKING RAP SHADES Hilco Corp. HQY Class I 1994-04-06
K940778 SUNGLASSES (NON-PRESCRIPTION) Hwa Meei Optical Co., Ltd. HQY Class I 1994-04-06
K935342 SCMD KERATOME S.C.M.D. Keratomes of Arizona HNO Class I 1994-04-01
K936209 SLIT LAMP, H-201 Canon USA, Inc. HJO Class II 1994-04-01
K935747 MEGABEAM ENDOCULAR PROBE Ceram Optec, Inc. HQF Class II 1994-04-01
K935099 SUNGLASSES Taiwan Tong AI Co., Ltd. HQY Class I 1994-04-01
K935302 OSHER SURGICAL GONIO/POSTERIOR POLE LENS Ocular Instruments, Inc. HKS Class I 1994-04-01
K940354 ORVIS MARQUESAS FISHING GLASSES The Orvis Co., Inc. HQY Class I 1994-03-24
K940275 UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD P.J. Products, Inc. HOY Class I 1994-03-24
K940292 ORVIS RIVER GUIDE GLASSES The Orvis Co., Inc. HQY Class I 1994-03-24
K934567 SUNGLASSES (NON-PERSCRIPTION) Jaan Huey Co., Ltd. HQY Class I 1994-03-24
K940213 UNIVERSAL CUSHIONED METAL EYE SHIELD P.J. Products, Inc. HOY Class I 1994-03-24
K935223 OPHTHALMIC SURGICAL SYSTEM Optical Micro Systems, Inc. HQC Class II 1994-03-14
K936027 SPORTS RADIO SUNGLASSES Vast Lea Enterprise Co. , Ltd. HQY Class I 1994-03-14
K933739 360 DEGREE FIXATION LIGHT Varitronics HPL Class I 1994-03-14
K933907 STORZ FIBEROPTIC PICK MANIPULATOR Storz Instrument Co. HQE Class II 1994-03-07
K940095 FOX EYE ALUMINUM SHIELD, OPHTHALMIC P.J. Products, Inc. HOY Class I 1994-03-01
K935251 MARTINEZ ORBITAL IMPLANT Miguel Martinez M.D. HPZ Class II 1994-03-01
K930840 POST-MYDS(TM) Aukland Medical Plastics, Inc. HOY Class I 1994-03-01
K940312 FRAME Lanner Enterprise Co., Ltd. HQZ Class I 1994-03-01
K931784 HGM ILLUMINATING IMAGING ENDOCULAR PROBE Hgm, Inc. HQF Class II 1994-03-01
K934570 SPECTACLE FRAMES Chaser Optical Corp. HQZ Class I 1994-03-01
K926540 SOPHER AND BIERER OVUM FORCEPS Thomasville Medical Assoc. HLZ Class II 1994-02-25
K930575 KAMPPETER ANOMALOSCOPE Bova Intl. HIW Class I 1994-02-25
K935920 SPECTACLE FRAME Cadore Moda USA, Inc. HQY Class I 1994-02-25
K932668 OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER Synergetics, Inc. HQE Class II 1994-02-23
K933633 LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE Gracefully Yours, Inc. HJG Class I 1994-02-22
K935968 SPECTACLE FRAMES Sae Biang Optical Co. HQZ Class I 1994-02-22
K931358 AORP4000 REUSABLE PAK American Optical Corp. HQC Class II 1994-02-22
K934663 60 DEGREE FUNDUS CAMERA, CF-60UD Canon USA, Inc. HKI Class II 1994-02-22
K936149 ELITE COLLECTION Omega Group, Inc. HQZ Class I 1994-02-22
K935969 SPECTACLE FRAMES Tae Kyung Optical Co., Inc. HQY Class I 1994-02-22
K935114 SUNGLASSES (NON-PRESCRIPTION) Promising Enterprise CO , Ltd. HQY Class I 1994-02-22
K933079 ELECTROCAUTERY SYSTEM MODEL 1980 Pmt Corp. HQP Class II 1994-02-22
K931354 P4000 PHACOEMULSIFIER American Optical Corp. HQC Class II 1994-02-22
K940113 EYEGLASS FRAME Wan Wing Optical Co. HQZ Class I 1994-02-22
K933819 SUNGLASSES California Bazar HQY Class I 1994-02-22
K936217 EYEGLASS FRAMES Ocean Optical Co., Inc. HQZ Class I 1994-02-22
K936018 REPLACEMENT BATTERIES PART NO. 5098,5135, 5097 R & D Batteries, Inc. HLJ Class II 1994-02-22
K935903 SPLASHMASTER PRESCRIPTION EYEWEAR Cabot Safety Corp. HQY Class I 1994-02-22
K931497 SUNGLASSES Wain Lin Trading Corp. HQY Class I 1994-02-22
K936146 SPECTACLE FRAMES Franel Optical HQY Class I 1994-02-22
K936004 OPTICAL FRAMES Europa Continental, Inc. HQZ Class I 1994-02-22
K936218 SEE MONSTERS SUNGLASSES Doppler, Inc. HQY Class I 1994-02-22
K935764 NON-PRESCRIPTION SUNGLASSES Airess, Inc. HQY Class I 1994-02-22
K940202 SPECTACLE FRAMES Sam Chung Optical Co., Ltd. HQZ Class I 1994-02-22
K931512 SUNGLASSES Alpina U.S.A. Eyewear, Inc. HQY Class I 1994-02-22
K936033 SUNGLASSES Tung Fang Mei Shieh Co., Ltd. HQY Class I 1994-02-22
K934466 SPECTACLE FRAMES Airess, Inc. HQZ Class I 1994-02-22
K925531 SOLARSHIELD CLIPS Dioptics Medical Products, Inc. HQY Class I 1994-02-22
K935988 R&D BATTERIES # 5615, 5234, 5097 R & D Batteries, Inc. HLI Class II 1994-02-22
K940201 PRESTIGE FRAMES Eye Think Eyewear HQZ Class I 1994-02-22
K936104 R & D BATTERIES R & D Batteries, Inc. HLJ Class II 1994-02-22
K925304 AUTOREF LENSMETER RL-10 Canon USA, Inc. HKO Class I 1994-02-17
K935446 VISUAL HEALTHSHIELDS Yorktowne Optical Co., Inc. HQY Class I 1994-02-17
K930113 KIRWAN IRRIGATION/ASPIRATION HANDPIECE Kirwan Surgical Products, Inc. HMX Class I 1994-02-17
K935918 SPECTACLE FRAME Kenmark Optical Co., Inc. HQZ Class I 1994-02-16
K935226 I/V POLE Optical Micro Systems, Inc. KYG Class I 1994-02-16
K930566 OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASS E.B. Brown Opticians HQZ Class I 1994-02-16
K935954 OPTICAL FRAME COLLECTION NO. 2 Frontier Novelty, Inc. HQZ Class I 1994-02-16
K935605 SPECTACLE FRAMES Sovereign Eyewear, Inc. HQZ Class I 1994-02-16
K935678 SUNGLASS FRAME Australian Optical Co., Inc. HQY Class I 1994-02-16
K934320 MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION Mentor O & O, Inc. HQR Class II 1994-02-16
K935919 SUNGLASSES Ja-Ru, Inc. HQG Class I 1994-02-16
K925828 MODIFIED SITE TXR SYSTEMS Site Microsurgical Systems, Inc. HQC Class II 1994-02-16
K930659 SUNGLASSES Kai Tai Optical Mfg. Co. , Ltd. HQY Class I 1994-02-16
K935798 MULTIPLE -SPECTACLE FRAMES/SUNGLASSES Tae Kyung Optical Co., Inc. HQZ Class I 1994-02-16
K935729 OPTICAL FRAMES AND/OR SUNGLASSES Ivo Eyewear, Inc. HQZ Class I 1994-02-16
K934277 SUNGLASSES Rainbow Optics, Inc. HQY Class I 1994-02-09
K934204 INTERTIP INFUSION SET Oasis Medical, Inc. HQE Class II 1994-02-07
K933627 PHACOFRAGMENTOR TIP M. Imonti and Associates Inc., HQC Class II 1994-01-25

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