meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
18
Latest Decision
1994-01-25

Clearances · page 29 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K934187 SPECTACLE FRAMES AND SUNGLASSES Wah Ming Optical Mfy. , Ltd. HQZ Class I 1994-01-25
K935107 SPECTACLE FRAMES Mr I'S Optical Boutique HQZ Class I 1994-01-25
K933189 SPECTACLE FRAMES AND SUNGLASSES Eastern Breeze Intl. Co. HQY Class I 1994-01-25
K930518 TALIA LASER SLIT Talia Technology , Ltd. HJO Class II 1994-01-25
K934197 OPTIKOS SHAMI, INC. SUNGLASSES Optikos Shami, Inc. HQY Class I 1994-01-25
K935558 SPECTACLE FRAME/EYEGLASS FRAME Modern Optical , Ltd. HQZ Class I 1994-01-25
K932821 APEX OPTICAL IND. CO., EYE WEA MODELS Apex Optical Ind. Co. HQZ Class I 1994-01-25
K934494 SURGITEL General Scientific Corp. HOH Class I 1994-01-25
K933984 STORZ FIBEROPTIC REVERSE CUTTING KNIFE Storz Instrument Co. HQE Class II 1994-01-25
K935003 ELECTRIC I/V POLE OR EIVP2 Optical Micro Systems, Inc. KYG Class I 1994-01-25
K931357 AOD4000 DISPOSABLE PAK American Optical Corp. HQC Class II 1994-01-25
K933223 SUNGLASSES Rally Accessories, Inc. HQY Class I 1994-01-25
K935231 TALE SPIN SUNSHADES Equity Marketing, Inc. HQY Class I 1994-01-25
K930174 GLASSES MOLASSES Arthur F. Kozakowski, Jr. HQZ Class I 1994-01-25
K934402 COOL KIDS MIRROR SHADES Ja-Ru, Inc. HQY Class I 1994-01-25
K933503 PRO-PHACO HANDPIECE M. Imonti and Associates Inc., HQC Class II 1994-01-06
K932469 VISUAL SCENE SUNGLASSES Vsi Intl., Inc. HQY Class I 1994-01-06
K935165 BIKER MICE SUNGLASSES Ja-Ru, Inc. HQY Class I 1994-01-06
K933938 FINE OPTICS SUNGLASSES Fine Optics, Inc. HQY Class I 1994-01-06
K935541 SUNGLASSES Seven Pyramid Ent Co., Ltd. HQY Class I 1994-01-06
K930195 OPHTHALMIC TRIAL LENSES Optimark Accessories and Instruments HPC Class I 1994-01-06
K934020 SUNGLASSES Sun Probe Enterprise Co., Ltd. HQY Class I 1994-01-06
K932439 SPECTACLE FRAMES Styl-Rite Optics, Inc. HQZ Class I 1994-01-03
K932151 FLOATS SUNGLASSES Floats, Inc. HQY Class I 1994-01-03
K933872 VISI-SPEAR EYE SPONGE Visitec Co. HOZ Class II 1993-12-27
K934859 CONTACT LENSES Arno Intl., Inc. HPC Class I 1993-12-21
K933323 RUSSELL & HANCOCK 524 AND 422 SUNGLASSES Russell & Hancock, Ltd. HQY Class I 1993-12-21
K934084 BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE Bioenterics Corp. HMJ Class I 1993-12-16
K933208 BARE-FIBER ENDOILLUMINATOR Surgical Technologies, Inc. HQE Class II 1993-12-14
K930331 SPECTACLE FRAME Australian Optical Co., Inc. HQZ Class I 1993-12-08
K934403 SUNGLASSES Sun Share Merchandise Corp. HQY Class I 1993-12-08
K934374 SUNGLASSES (NON-PRESCRIPTION) Immmex Company , Ltd. HQY Class I 1993-12-08
K934301 SPECTACLE FRAMES Gernot Lindner, Lunor-Vertrieb HQZ Class I 1993-12-08
K934797 FINE OPTICS Fine Optics, Inc. HQZ Class I 1993-12-08
K934858 FRAME SPECTACLE Arno Intl., Inc. HQZ Class I 1993-12-08
K934837 SUNGLASSES Simon Marketing, Inc. HQY Class I 1993-12-08
K925539 SUNGLASSES Sunshine Opticians, Inc. HQY Class I 1993-12-08
K934463 SPECTACLE FRAME Good Bond Industrial Corp. HQZ Class I 1993-12-08
K934852 COOL KIDS HIP SHADES Ja-Ru, Inc. HQY Class I 1993-12-08
K926381 OCUSYSTEM IIE Surgeon Design HQC Class II 1993-12-06
K925921 MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE Site Microsurgical Systems, Inc. KYG Class I 1993-12-06
K925755 DE LUXE Rudolf Riester GmbH & Co. KG HLJ Class II 1993-12-03
K931839 ROTA SYSTEM XL Rota Systems Medfurniture, Inc. HMF Class I 1993-11-22
K932836 NIDEK MODEL AC-2300 Nidek, Inc. HQF Class II 1993-11-22
K931866 SITE'S CD II PHACOEMULSIFICATION HANDPIECE Site Microsurgical Systems, Inc. HQC Class II 1993-11-12
K931254 GOGGLE SAFEGUARD Sellstrom Mfg. Co. HOY Class I 1993-11-12
K934400 REVO CLASSIC/SHAPES SUNGLASSES Revo, Inc. HQY Class I 1993-11-12
K932296 JR -- OPHTHALMIC ARGON LASER Carson Laserworks HQF Class II 1993-11-12
K925636 AHMED GLAUCOMA VALVE IMPLANT New World Medical, Inc. KYF Class II 1993-11-12
K923531 OPTOSCALPEL I LASER SYSTEM Optomed Corp. HQB Class II 1993-11-12
K930585 SUNGLASSES Daiko S.R.L. HQY Class I 1993-11-12
K934085 MODIFICATION OF SURGICAL EYESHIELD MASK American Threshold Industries, Inc. HOY Class I 1993-11-12
K934309 DISCO SUNGLASSES NONPRESCRIPTION SUNGLASSES U.S. Toy Co., Inc. HQY Class I 1993-11-02
K931990 SUNGLASSES American Eye Way, Inc. HQY Class I 1993-11-02
K934249 TRACTION PRODUCTIONS SPECTACLE FRAMES Traction Productions, USA HQZ Class I 1993-11-02
K933556 EH-270 CORNEAL TOPOGRAPHER Visioptic, Inc. HLQ Class I 1993-11-02
K934308 CHILD NONPRESCRIPTION SUNGLASSES U.S. Toy Co., Inc. HQY Class I 1993-11-02
K934307 BUTTERFLY NONPRESCRIPTION SUNGLASSES U.S. Toy Co., Inc. HQY Class I 1993-11-02
K934304 ANIMAL NONPRESCRIPTION SUNGLASSES U.S. Toy Co., Inc. HQY Class I 1993-11-02
K931451 GLASSES Siegel Optik HQY Class I 1993-11-02
K932416 PROMOTIONAL SUNGALSSES Associated Premium Corp. HQY Class I 1993-11-02
K934305 AVIATOR NONPRESCRIPTION SUNGLASSES U.S. Toy Co., Inc. HQY Class I 1993-11-02
K933529 EYEGLASSES FRAMES Vistula Assistance & Consulting Bureau HQZ Class I 1993-10-20
K930956 SIGMA-BRILLEN (OR) MULTIPLE Sigma-Brillen HQZ Class I 1993-10-20
K930858 MODISSA 90 S.R.L. SUNGLASSES Modissa 90 Srl HQY Class I 1993-10-20
K933089 FASHION ITALIANA EYEWEAR Fashion Italiana, Inc. HQY Class I 1993-10-18
K934120 NON-PRESCRIPTION EYEGLASS FRAMES & SUNGLASSES VARIOUS STYLES Lux DE Paris, Inc. HQY Class I 1993-10-18
K933718 MUGNIER JERIK SUNGLASSES Huntley Global Ent. HQY Class I 1993-10-18
K930937 LD 400 Vismed, Inc. HPT Class I 1993-10-18
K933991 SPECTACLE FRAMES U.S. Optical HQZ Class I 1993-10-18
K933865 FRAMES Hillman'S, the Eyecare Co., Inc. HQZ Class I 1993-10-18
K933891 SPECTACLE FRAMES Euro Frame Design, Inc. HQZ Class I 1993-10-18
K933956 ALDO'S OPTICAL FRAME COLLECTION Frontier Novelty, Inc. HQZ Class I 1993-10-18
K934034 SPECTACLE SUNGLASSES (NON-PERSCRIPTION) H.M.O. Optical, Inc. HQY Class I 1993-10-18
K933809 OPTO LINE SRL Optoline S.R.L. HQZ Class I 1993-10-18
K925756 UNI II Rudolf Riester GmbH & Co. KG HLJ Class II 1993-10-18
K933905 ASICS SUNGLASSES Asics Tiger Corp. HQY Class I 1993-10-18
K934082 SPECTACLE FRAMES South American Optical, Inc. HQZ Class I 1993-10-18
K934081 SPECTACLE SUN GLASSES (NON PRESCRIPTION) South American Optical, Inc. HQY Class I 1993-10-18
K933765 FRAME-SPECTACLE Clearvision Optical Co., Inc. HQZ Class I 1993-10-18
K932504 RI-FORMER Rudolf Riester GmbH & Co. KG HLJ Class II 1993-10-15
K933453 MULTIPLE Fortuna Optical Factory , Ltd. HQZ Class I 1993-10-13
K925564 ACTION MEDTEK/DENTEK EYEGLASSES Action Eyewear Corp. HOY Class I 1993-10-07
K932838 SUNGLASSES AND OPTICAL FRAMES, CARBON AND METAL FRAMES Wonderful Optical Co., Ltd. HQY Class I 1993-10-06
K931389 ITEM # 754 HOT FLIP SHADES Ja-Ru, Inc. HQY Class I 1993-10-06
K933452 MULTIPLE Tae Han Optical Ent. HQZ Class I 1993-10-06
K934198 OPTIKOS SHAMI, INC. SPECTACLE FRAMES Optikos Shami, Inc. HQZ Class I 1993-10-04
K934033 SPECTACLE FRAMES H.M.O. Optical, Inc. HQZ Class I 1993-10-04
K932992 SPECTACLE FRAMES Vivid Optical Co., Ltd. HQZ Class I 1993-10-01
K931431 FLOATER SUNGLASSES Floater Eyewear, Inc. HQY Class I 1993-10-01
K933429 MULTIPLE Sam Chung Optical Co., Ltd. HQZ Class I 1993-10-01
K931055 ITEM # 755 HOT SUNGLASSES South American Industrial Co. HQY Class I 1993-10-01
K932125 OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES Vision Design Eyewear, Inc. HQZ Class I 1993-10-01
K933138 INFLUENCE,ARIA,MASERATI,ROCHAS,ANGELO,TARLAZZI Aria Advanced Eyewear, Inc. HQY Class I 1993-10-01
K931911 BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMES Brillenerzeugung Pomberger HQZ Class I 1993-10-01
K925187 ALIBI OPTICAL FRAMES AND SUNGLASSES Alibi Designs, Inc. HQY Class I 1993-10-01
K931910 BRILLENERZEUGUNG POMBERGER OR MULTIPLE SUNGLASSES Brillenerzeugung Pomberger HQY Class I 1993-10-01
K933733 MARCHON/MARCOLIN EYEGLASSES Marchon Eyewear, Inc. HQZ Class I 1993-10-01
K932275 SUNGLASSES Kam Cheong Plastic Factory , Ltd. HQY Class I 1993-10-01
K925570 SUNGLASSES De'Vons Products, Inc. HQY Class I 1993-10-01

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