meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
17
Latest Decision
1994-08-05

Clearances · page 26 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K942302 ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS Preferred Optics, Inc. LPL Class II 1994-08-05
K942721 NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 Neitz Instruments Company, Ltd. HLJ Class II 1994-08-05
K943198 SPECTACLE FRAMES Lunettes Folomi S.A. HQZ Class I 1994-08-05
K942712 NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A Neitz Instruments Company, Ltd. HLI Class II 1994-08-05
K942714 NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP Neitz Instruments Company, Ltd. HLI Class II 1994-08-05
K942897 OPTHALMIC WIPE Surgin Surgical Instrumentation, Inc. HQZ Class I 1994-08-05
K943507 WINK EYEWEAR Wink Optical, Inc. HQZ Class I 1994-08-05
K942533 NOVALENS/NOVAWET PERCEPTION AND VANGUARD Ocutec Corporation, Inc. HQD Class II 1994-08-05
K942713 NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H Neitz Instruments Company, Ltd. HLI Class II 1994-08-05
K942717 NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A Neitz Instruments Company, Ltd. HLJ Class II 1994-08-05
K943265 N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO The First Optical Manufactory , Ltd. HQZ Class I 1994-08-05
K942478 VISARD FRAMES Iris Optical, Inc. HQZ Class I 1994-08-05
K942715 NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC Neitz Instruments Company, Ltd. HLI Class II 1994-08-05
K943352 SPOMA INTERNATIONAL CORPORATION Spoma Intl. Corp. HQY Class I 1994-08-05
K942104 KEELER VANTAGE INDIRECT OPHTHALMOSCOPE Keeler Instruments, Inc. HLI Class II 1994-08-04
K943082 SPECTACLE FRAME Daewon Optical Co. HQZ Class I 1994-08-04
K943085 SPECTACLE FRAME Winntics Optical Industry Co. , Ltd. HQZ Class I 1994-08-04
K942845 PERSOL, MOSCLHINO, AND GERALD GENTA Persol America, Inc. HQZ Class I 1994-08-04
K940561 SUNGLASSES Hibiscus Ind. Co. , Ltd. HQY Class I 1994-08-04
K936125 SPECTACLE FRAMES, SUNGLASSES Eyedesigns Corp. HQY Class I 1994-08-04
K941148 SUNGLASSES Metal Dream S.R.L. HQY Class I 1994-08-04
K943183 CIBA VISION(R) CONTACT LENS CASE Ciba Vision Corporation LRX Class II 1994-08-04
K940088 MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE Medical Technical Products HQC Class II 1994-08-04
K943161 ORVIS DRIVING GLASSES The Orvis Co., Inc. HQY Class I 1994-08-04
K943328 EVERYTHING KIDS Jcc Co., Inc. HQY Class I 1994-08-04
K943131 ORVIS POLARIZED BI-FOCALS The Orvis Co., Inc. HQY Class I 1994-08-02
K941929 SUNGLASSES Top Champ, Inc. HQY Class I 1994-08-02
K943443 SUNGLASSES Sunny Union Industrial Co., Ltd. HQY Class I 1994-08-02
K943083 SPECTACLE FRAME Pimex Co., Ltd. HQZ Class I 1994-08-02
K943236 OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX Optiline Imports and Trade, Inc. HQZ Class I 1994-08-02
K943086 SPECTACLE FRAME Radiant Spectacles Manufacturers HQZ Class I 1994-08-02
K943442 SPECTACLE FRAMES Sunny Union Industrial Co., Ltd. HQZ Class I 1994-08-02
K941540 SUNGLASSES Tonview International Co., Ltd. HQY Class I 1994-08-02
K942951 ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS The Orvis Co., Inc. HQY Class I 1994-08-02
K943102 HIGH PERFORMANCE TIPS Surgin Surgical Instrumentation, Inc. HQC Class II 1994-07-28
K942186 ESSTECH PS ASPHERIC Szabocsik and Assoc. LPL Class II 1994-07-28
K942214 H55 HYDROPHILIC CONTACT LENS Martin S. Knopf Assoc., Inc. LPL Class II 1994-07-28
K942187 ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS Szabocsik and Assoc. LPL Class II 1994-07-28
K943234 MS-30 AUTOMATIC PERIMETER Marco Ophthalmic, Inc. HPT Class I 1994-07-27
K926564 OPTICAL FRAMES AND SUNGLASSES Solstar Produktions GmbH HQY Class I 1994-07-27
K942932 GLADIATOR Gladiator Sports HQY Class I 1994-07-27
K943202 EASSUN HI-TECH OPTICS Ultimate Concepts, Inc. HQY Class I 1994-07-27
K934600 MICRODRIVE Medical Instrument Development Laboratories, Inc. HQE Class II 1994-07-27
K943084 SPECTACLE FRAME Samil Enterprise Co. HQZ Class I 1994-07-25
K942516 10-0 CASSETTE Surgin Surgical Instrumentation, Inc. HQC Class II 1994-07-25
K942952 ORVIS WORLD FINEST POLARIZED CLIP ONS The Orvis Co., Inc. HQY Class I 1994-07-25
K942037 SUNGLASSES Golden Year Supply Co. HQY Class I 1994-07-25
K942038 SUNGLASSES Golden Year Supply Co. HQY Class I 1994-07-25
K942673 NON-PRESCRIPTION SUNGLASSES Angel Eyewear HQY Class I 1994-07-25
K942515 PHACO KIT Surgin Surgical Instrumentation, Inc. HQC Class II 1994-07-25
K942518 CASSETTE SYSTEM FOR SITE Surgin Surgical Instrumentation, Inc. HQC Class II 1994-07-25
K942517 10-K CASSETTE Surgin Surgical Instrumentation, Inc. HQC Class II 1994-07-25
K942001 SUNGLASSES Hung Wai Optical Co. HQY Class I 1994-07-25
K942750 SPECTACLE FRAMES Aspex Eyewear, Inc. HQZ Class I 1994-07-25
K942067 SAM SUNG OPTICAL Sam Sung Optical HQY Class I 1994-07-25
K940925 SUNGLASSES Gold Link Design , Ltd. HQY Class I 1994-07-25
K932484 MARS SUNGLASSES Mars Promotional Services, Inc. HQY Class I 1994-07-25
K941874 SUNGLASSES The Fair Optical Ent.Co. , Ltd. HQY Class I 1994-07-25
K940372 SUNGLASSES, SPECTACLE FRAMES Giorgio Nannini Srl HQY Class I 1994-07-25
K941581 HAPPY EYES OPTICAL CO. SUNGLASSES Happy Eye Optical Co. HQY Class I 1994-07-25
K932258 OPTICOM M600 Clement Clarke, Inc. HPT Class I 1994-07-25
K942755 NIL Ever Great International , Ltd. HQY Class I 1994-07-25
K926412 MICRON-SCOPE II Chiron Vision Corp. HMS Class I 1994-07-19
K940373 OPHTHALMIC CRYO UNIT Dutch Ophthalmic USA, Inc. HPS Class II 1994-07-18
K941705 NERVE FIBER ANALYZER Carl Zeiss Meditec, Inc. HLI Class II 1994-07-18
K936302 NIDEK MODEL VT-4000, MODIFICATION Nidek, Inc. HQE Class II 1994-07-15
K942783 NON-PRESCRIPTION SUNGLASSES Sunpoint Import Co., Inc. HQY Class I 1994-07-15
K942642 SURGI-WIPE Surgin Surgical Instrumentation, Inc. HOZ Class II 1994-07-15
K941495 RETURN PATH DIATHERMY HANDLE Mira, Inc. HQR Class II 1994-07-15
K936072 NON-PRESCRIPTION SUNGLASSES King'S Sunglass Corp. HQY Class I 1994-07-15
K942119 U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES U-Top Enterprise Co., Ltd. HQY Class I 1994-07-15
K942513 SEIKO EYEGLASS FRAME Seiko Optical Products of America, Inc. HQZ Class I 1994-07-15
K941053 NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES Hsin Chen Intl. Co., Ltd. HQY Class I 1994-07-12
K941441 NON-PRESCRIPTION SUNGLASSES Sun-Set Enterprise Co. , Ltd. HQY Class I 1994-07-12
K940625 CHEN SHUENG ENTERPRISE CO. Sunny Sunglasses HQY Class I 1994-07-12
K942652 SCHOOL MASCOT EYEWEAR School Mascot Eyewear, Inc. HQY Class I 1994-07-12
K941555 SUNGLASSES/VARIOUS COLLECTIONS Atlantic Optical Co., Inc. HQY Class I 1994-07-12
K941047 WESTERN TRADING CO Eva Optiks, Inc. HQY Class I 1994-07-12
K942588 NON-PRESCRIPTION SUNGLASSES Pro Axess HQY Class I 1994-07-12
K942348 PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC. Oliver Peoples, Inc. HQZ Class I 1994-07-12
K942500 SUNGLASSES TOKYO BAY Tokyo Bay, Inc. HQY Class I 1994-07-12
K925596 NON-PRESCRIPTION SUNGLASSES European & Foreign Imports, Inc. HQY Class I 1994-07-12
K940629 YEOU NAN SUNGLASSES CO Sunny Sunglasses HQY Class I 1994-07-12
K941414 EYECOTECH CORP Eyecotech Corp. HQZ Class I 1994-07-12
K940516 AUTO REFF-30 Canon, Inc. HKO Class I 1994-07-12
K940626 CLEVER OPTICAL INDUSTRIES LTD Sunny Sunglasses HQY Class I 1994-07-12
K940628 JIHN MEI OPTICAL CO. Sunny Sunglasses HQY Class I 1994-07-12
K940488 CHEN-HERSIN SUNGLASSES Chen Hersin Ent. HQY Class I 1994-07-12
K940627 WENZHOU IMPORT AND EXPORT CORP Sunny Sunglasses HQY Class I 1994-07-12
K941538 SUNGLASSES Solar Sunglasses Corp. HQY Class I 1994-07-12
K940924 SUNGLASSES Sunny Sunglasses HQY Class I 1994-07-12
K942463 FRAME, SPECTACLE Erica Optical Co. HQZ Class I 1994-07-12
K941910 SUNGLASSES The Orvis Co., Inc. HQY Class I 1994-07-08
K941836 UNILENS 38 SOFT ASPHERIC CONTACT LENS Unilens Corp., USA LPL Class II 1994-07-07
K942372 SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS Unilens Corp., USA LPL Class II 1994-07-07
K941785 SUNGLASSES K. L. Wings Co., Ltd. HQY Class I 1994-07-06
K940647 ORBSCAN(TM) KERATOMETER Orbtek, Inc. HLQ Class I 1994-07-06
K941603 AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE Allergan Medical Optics KYB Class I 1994-07-06
K942039 SUNGLASSES Valiente Co., Ltd. HQY Class I 1994-06-30
K940592 SUNGLASSES Sunblue Intl., Inc. HQY Class I 1994-06-30

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