meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
29
Latest Decision
1993-10-01

Clearances · page 30 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931408 SUNGLASSES Sunnycraft Philippines, Inc. HQY Class I 1993-10-01
K931972 FRAME - SPECTACLE Eyetel Optics, Inc. HQZ Class I 1993-10-01
K932773 FRAMES, SPECTACLES Diaco, Inc. HQZ Class I 1993-09-20
K933074 SUNGLASSES P.T. Sun and Young Indonesia Sunglasses HQZ Class I 1993-09-20
K933874 SPECTACLE FRAME Designer Frames HQZ Class I 1993-09-20
K932646 ROLLENS POST-MYDRIATIC SUNGLASS Rollens Professional Products, Inc. HQY Class I 1993-09-20
K931718 SPIRIT SHIELD Eaton Medical Corp. HQY Class I 1993-09-20
K933423 STETSON/S.LOREN/LH.BAZAAR/G.VANDERBILT/P.BALMAIN Thunder Industries, Inc. HQZ Class I 1993-09-20
K933254 EYEGLASS FRAMES Sam Chung Optical Co., Ltd. HQY Class I 1993-09-20
K932814 NON-PRESCRIPTION SUGLASSES Sun Style Intl. Corp. HQY Class I 1993-09-20
K932772 FRAMES, SPECTACLES Optical Designs and Sourcing, Inc. HQZ Class I 1993-09-20
K933734 MARCHON/MARCOLIN SUNGLASSES Marchon Eyewear, Inc. HQY Class I 1993-09-20
K932941 SUNGLASSES Rayman Speco Co., Ltd. HQY Class I 1993-09-20
K925428 SUNGLASSES Dallas Handbag Co. HQY Class I 1993-09-20
K931504 SUNGLASSES The B & F System, Inc. HQY Class I 1993-09-20
K933616 MULTIPLE Greg and Greg, Inc. HQY Class I 1993-09-20
K932939 SUNGLASSES Soft-Ray Optical Corp. HQY Class I 1993-09-20
K933424 STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN Zyloware Corp. HQZ Class I 1993-09-20
K930435 SPECTACLE FRAMES Venis DI A. Vendrame HOI Class I 1993-09-20
K932940 SUNGLASSES Sun and Young Sunglasses Co., Ltd. HQY Class I 1993-09-20
K926096 NON-PRESCRIPTION SUNGLASSES Lunettes Bondet HQY Class I 1993-09-20
K925641 ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR Carl Zeiss, Inc. HJO Class II 1993-09-09
K933313 SPECTACLE FRAMES Serrao Optical Intl., Inc. HQZ Class I 1993-09-09
K932802 SPECTACLE FRAME Insight Optical Mfg. Co. of Florida, Inc. HQZ Class I 1993-09-09
K933436 FRAME, SPECTACLE Aoyama Optical Co., Ltd. HQZ Class I 1993-09-09
K926512 STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE Storz HQC Class II 1993-09-09
K932999 NEW STAR, TAE HAN OPTICAL J.B. Eyewear, Inc. HQZ Class I 1993-09-09
K931356 SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR Sorenson Laboratories, Inc. LQJ Class II 1993-09-07
K925224 U108, U105, G209-B Custom Optical Frames, Inc. HQY Class I 1993-09-01
K932813 FRAMES, SPECTACLE Rainbow Optics, Inc. HQZ Class I 1993-08-31
K933280 SPECTACLE FRAMES U.S. Optical HQZ Class I 1993-08-31
K931449 MSP OPHTHALMIC (EYE SPUD) Medical Sterile Products, Inc. HNA Class I 1993-08-31
K932906 SPECTACLE FRAMES U.S. Optics, Inc. HQZ Class I 1993-08-31
K930857 MODISSA 90 S.R.L. SPECTACLE FRAMES Modissa 90 Srl HQZ Class I 1993-08-25
K925741 CLARUS ENDOSCOPIC HOOK KNIFE Clarus Medical Systems, Inc. HLX Class II 1993-08-24
K930198 LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) Forda (China) Optical Co. HQY Class I 1993-08-23
K925663 HGM ASPIRATING ENDOOCULAR(TM) PROBE Hgm, Inc. HQF Class II 1993-08-17
K930562 SOLSTAR BRILLENMODE SUNGLASSES Solstar Produktions GmbH HQY Class I 1993-08-17
K931328 PYRAMID SUNGLASSES/PYRAMID READING GLASSES Pyramid HOI Class I 1993-08-10
K932018 OUT FOR FUN! HAPPY MEAL MCDONALDLAND SUNGLASSES Simon Marketing, Inc. HQY Class I 1993-08-10
K931525 SUNGLASSES Premiums Promotions & Imports, Inc. HQY Class I 1993-08-09
K930442 MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS Marco Ophthalmic, Inc. HKI Class II 1993-08-09
K930437 MARCO STANDARD RADIUSGAUGES Marco Ophthalmic, Inc. HLF Class I 1993-08-09
K930444 MARCO STANDARD KERATOMETERS Marco Ophthalmic, Inc. HJB Class I 1993-08-09
K930438 MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS Marco Ophthalmic, Inc. HJO Class II 1993-08-09
K932135 OTT SUNGLASSES Sunnex Fashion Corp. HQY Class I 1993-08-06
K926065 EYEGLASS FRAMES AND SUNGLASSES Palm Optical Co., Inc. HQY Class I 1993-08-05
K931648 SPECTACLE FRAMES Eye Care Centers of America, Inc. HQZ Class I 1993-08-05
K925757 OPHTHALMOSCOPE Rudolf Riester GmbH & Co. KG HLJ Class II 1993-08-03
K931135 ALTAIR EYEWEAR FRAMES Altair Eyewear HQZ Class I 1993-08-02
K930597 SPECTACLE FRAMES Venis DI Alessandro Vendrame HQZ Class I 1993-08-02
K925671 DISPOSABLE SCLERAL PLUGS O.R. Specialties, Inc. LXP Class II 1993-08-02
K933133 SPECTACLE FRAMES Solitaire Designs, Ltd. HQZ Class I 1993-08-02
K925803 A.J. MORGAN SUNGLASSES A.J. Morgan Ent. HQY Class I 1993-07-29
K925631 PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE Chiron Intraoptics HQC Class II 1993-07-29
K926470 LASER AND EMPHASIS SCLEROSTOMY TIP Summit Technology, Inc. HQF Class II 1993-07-22
K922886 VARIOUS MODELS OF SUNGLASSES Hard Rock Cafe, Inc. HQY Class I 1993-07-13
K930443 MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE Marco Ophthalmic, Inc. HOS Class I 1993-07-06
K930446 MARCO TRIAL SETS Marco Ophthalmic, Inc. HPC Class I 1993-07-06
K930440 MARCO INTERNATIONAL STAND Marco Ophthalmic, Inc. HMF Class I 1993-07-06
K930447 MARCO H AND TS-1 INSTRUMENT TABLES Marco Ophthalmic, Inc. HRJ Class I 1993-07-06
K930441 MARCO STANDARD LENSMETERS 101,201 Marco Ophthalmic, Inc. HLM Class I 1993-07-06
K930449 MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR Marco Ophthalmic, Inc. HME Class I 1993-07-06
K925736 NON-PRES SUNGLASSES/SPEC FRAMES (PLASTIC & METAL) Eyeworks 3 HQY Class I 1993-06-28
K931620 OPTI-FREE CONTACT LENS CASE Alcon Laboratories LRX Class II 1993-06-28
K921443 TIP & MEMBRANE ASSEMBLY Bio-Rad HKX Class II 1993-06-22
K922120 SERIOUS SKINGLASSES Serious Skinglasses HQY Class I 1993-06-21
K930023 MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE Welch Allyn, Inc. HLI Class II 1993-06-21
K930445 MARCO LM-770 DIGITAL PROJECTION LENSMETER Marco Ophthalmic, Inc. HLM Class I 1993-06-21
K930448 MARCO PROJECTION PERIMETER Marco Ophthalmic, Inc. HOO Class I 1993-06-21
K923746 MMELALENS SUNGLASSES Dwh, Inc. HQY Class I 1993-06-21
K923374 VARIOUS SUNGLASSES Playtime Products, Inc. HQY Class I 1993-06-09
K923375 PLAYSKOOL SUNGLASSES Playtime Products, Inc. HQY Class I 1993-06-09
K923778 SUNGLASSES Cyrk Intl., Inc. HQY Class I 1993-06-07
K923458 CONTACT LENS CASE Nomax, Inc. LRX Class II 1993-05-12
K926157 EYEGLASS FRAME Roi Factory Direct Frame Co. HQZ Class I 1993-05-06
K930561 SOLSTAR BRILLENMODE SPECTACLE FRAMES Solstar Produktions GmbH HQZ Class I 1993-05-03
K924786 BURTON TRIAL LENS SET R.H. Burton Co. HPC Class I 1993-04-14
K924783 BURTON SLIT LAMP - MODEL 850 R.H. Burton Co. HJO Class II 1993-04-14
K924774 BURTON AUTOMATIC PROJECTOR - MODEL CP-40 R.H. Burton Co. HOD Class I 1993-04-14
K924741 OPTEC 3000 Stereo Optical Co., Inc. HKO Class I 1993-04-06
K924548 XENO MELANIN LENS Photoprotective Technologies HQY Class I 1993-04-06
K924938 THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES Eyeworks 3 HQY Class I 1993-04-06
K924785 BURTON RADIUSGAUGE - MODEL 2030 R.H. Burton Co. HLM Class I 1993-04-05
K924777 BURTON APPLANATION TONOMETER - MODEL T850 & T1000 R.H. Burton Co. HKX Class II 1993-04-05
K924776 BURTON LENSMETER - MODEL 2021 R.H. Burton Co. HLM Class I 1993-04-05
K924788 BURTON LENSMETER R.H. Burton Co. HLM Class I 1993-04-05
K924790 BURTON AUTO REFRACTOR - MODEL BAR-7 R.H. Burton Co. HKO Class I 1993-04-05
K924778 BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 R.H. Burton Co. HKO Class I 1993-04-05
K924779 BURTON KERATOMETER - MODLE 2040 R.H. Burton Co. HJB Class I 1993-04-05
K924780 BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 R.H. Burton Co. HMF Class I 1993-04-05
K924784 BURTON PROJECTOR HEAD - MODEL 6000-H R.H. Burton Co. HOS Class I 1993-04-05
K924771 BURTON OPHTHALMIC STAND - MODEL XL3200 R.H. Burton Co. HMF Class I 1993-04-05
K924760 TOMEY PROTON TONOMETER Tomey Corporation USA HKY Class II 1993-04-05
K924353 NIDEK MODEL VST-4000 Nidek, Inc. HQE Class II 1993-03-29
K923543 MIS Ceram Optec, Inc. HLJ Class II 1993-03-29
K924260 NIDEK CV-12000 Nidek, Inc. HQC Class II 1993-03-26
K923742 TOPOGRAPHIC SCANNING SYSTEM TOPSS Carl Zeiss Meditec, Inc. HLI Class II 1993-03-26
K923708 LEMPERT OPTIC DISC ANALYSIS SYSTEM Lempert Ophthalmic Instruments HKI Class II 1993-03-19
K923922 SURGICAL SPEARS Ultracell Medical Technologies, Inc. HOZ Class II 1993-03-19

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