Ophthalmic

HQZ · Frame, Spectacle

Ophthalmic · 21 CFR 886.5842 · Class 1

Overview

Product CodeHQZ
Device NameFrame, Spectacle
Regulation21 CFR 886.5842
Device ClassClass 1
Review PanelOphthalmic

Identification

A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

Cleared Devices (198)

RecordDevice NameApplicantDecision DateDecision
K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.Sep 12, 1995SESE
K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.Mar 28, 1995SESE
K945770OPTICAL FRAMESRamada Optics, Inc.Dec 15, 1994SESE
K945392SPECTACLE FRAMESeo Han Corp., Ltd.Dec 15, 1994SESE
K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.Dec 15, 1994SESE
K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.Dec 13, 1994SESE
K945342MAG-1 SPECTACLE FRAMECriss Optical Mfg. Co., Inc.Nov 28, 1994SESE
K945450FRAME, SPECTACLEKookje Apis Industrial Co.Nov 22, 1994SESE
K945340SPECTACLE FRAMES OR EYEGLASS FRAMESMi Mun Corp.Nov 22, 1994SESE
K945323SPECTACLE FRAMEM.Y. Vision Corp.Nov 22, 1994SESE
K945123ARISTAR EYEWEAR, ESPRIT EYEWEARAristar Inc. U.S.A.Nov 22, 1994SESE
K944641NILMax-Vision (H.K.)LimitedNov 14, 1994SESE
K944373SPECTACLE FRAMESCustom Optical Frames, Inc.Sep 28, 1994SESE
K944160SILHOUETTE, SUNLIMETED,ADIDASSilhouette Optical , Ltd.Sep 28, 1994SESE
K943792SPECTACLE FRAMESKt Optique, Inc.Sep 14, 1994SESE
K943641SPECTACLE FRAMEAustralian Optical Co., Inc.Sep 14, 1994SESE
K943561SPECTACLE FRAMEAustralian Optical Co., Inc.Sep 14, 1994SESE
K943913MAX FRAME DESIGNNoble OpticSep 7, 1994SESE
K943423SPECTACLE FRAMESGalilee OpticsSep 6, 1994SESE
K943753FRAME SPECTACLEOptic Tech Corp.Sep 2, 1994SESE
K943567FACONNABLE EYEWEARBlink Designs, Inc.Aug 10, 1994SESE
K943326SPECTACLE FRAMESBuffard-La-DoyeAug 10, 1994SESE
K943507WINK EYEWEARWink Optical, Inc.Aug 5, 1994SESE
K943265N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMOThe First Optical Manufactory , Ltd.Aug 5, 1994SESE
K943198SPECTACLE FRAMESLunettes Folomi S.A.Aug 5, 1994SESE
K942897OPTHALMIC WIPESurgin Surgical Instrumentation, Inc.Aug 5, 1994SESE
K942478VISARD FRAMESIris Optical, Inc.Aug 5, 1994SESE
K943085SPECTACLE FRAMEWinntics Optical Industry Co. , Ltd.Aug 4, 1994SESE
K943082SPECTACLE FRAMEDaewon Optical Co.Aug 4, 1994SESE
K942845PERSOL, MOSCLHINO, AND GERALD GENTAPersol America, Inc.Aug 4, 1994SESE
K943442SPECTACLE FRAMESSunny Union Industrial Co., Ltd.Aug 2, 1994SESE
K943236OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEXOptiline Imports and Trade, Inc.Aug 2, 1994SESE
K943086SPECTACLE FRAMERadiant Spectacles ManufacturersAug 2, 1994SESE
K943083SPECTACLE FRAMEPimex Co., Ltd.Aug 2, 1994SESE
K943084SPECTACLE FRAMESamil Enterprise Co.Jul 25, 1994SESE
K942750SPECTACLE FRAMESAspex Eyewear, Inc.Jul 25, 1994SESE
K942513SEIKO EYEGLASS FRAMESeiko Optical Products of America, Inc.Jul 15, 1994SESE
K942463FRAME, SPECTACLEErica Optical Co.Jul 12, 1994SESE
K942348PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.Oliver Peoples, Inc.Jul 12, 1994SESE
K941414EYECOTECH CORPEyecotech Corp.Jul 12, 1994SESE
K941463SPECTACLE FRAMES, READING GLASSESWell Arts Optical Factory , Ltd.Jun 17, 1994SESE
K941211SPECTACLE FRAMESH & M Optical (U.S.A.) , Ltd.Jun 17, 1994SESE
K940733SPECTACLE FRAMES (V.I.P. INT'L)Continental Optical ImportsJun 17, 1994SESE
K941767FRAMES - VARIOUS BRAND NAMESLenscraft, Inc.Jun 3, 1994SESE
K941602SPECTACLE FRAMESSlim OcchialiJun 3, 1994SESE
K941523SPECTACLE FRAMESAmore Mio, Inc.May 17, 1994SESE
K941307SPECTACLE FRAMESEyemart Express, Inc.May 17, 1994SESE
K940504SPECTACLE FRAMESTecnol-Tecnica Nacional DE Oculos LtdaMay 17, 1994SESE
K940977SPECTACLE FRAMESSuper Optical, Inc.Apr 29, 1994SESE
K941059FRONTIER NOVELTY DAELIM OPTICAL FRAMEFrontier Novelty, Inc.Apr 12, 1994SESE
K941052EYEGLASS SPECTACLE FRAMES VARIOUS COLLECTIONSAtlantic Optical Co., Inc.Apr 12, 1994SESE
K940853MORRISON FRAME, SPECTACLEMorrison CenterApr 12, 1994SESE
K940782ARTSUN OPTICAL FRAMEFrontier Novelty, Inc.Apr 12, 1994SESE
K940077SPECTACLE FRAMES (WING SHING OPTICAL)Continental Optical ImportsApr 12, 1994SESE
K940411EYEGLASS FRAMES (PLASTIC)Value Line Optical Services, Inc.Apr 11, 1994SESE
K940614E.M.A.European Manufacturers Agency, Inc.Apr 6, 1994SESE
K940560SPECTACLE FRAMESOptical Xpressions, Ltd.Apr 6, 1994SESE
K940326SPECTACLE FRAMED'Tochi, Inc.Apr 6, 1994SESE
K935845SPECTACLE FRAMESNew Star Corp.Apr 6, 1994SESE
K932612DAELIM CORP. EYE WEAR MODELDaelim Corp.Apr 6, 1994SESE
K940312FRAMELanner Enterprise Co., Ltd.Mar 1, 1994SESE
K934570SPECTACLE FRAMESChaser Optical Corp.Mar 1, 1994SESE
K940202SPECTACLE FRAMESSam Chung Optical Co., Ltd.Feb 22, 1994SESE
K940201PRESTIGE FRAMESEye Think EyewearFeb 22, 1994SESE
K940113EYEGLASS FRAMEWan Wing Optical Co.Feb 22, 1994SESE
K936217EYEGLASS FRAMESOcean Optical Co., Inc.Feb 22, 1994SESE
K936149ELITE COLLECTIONOmega Group, Inc.Feb 22, 1994SESE
K936004OPTICAL FRAMESEuropa Continental, Inc.Feb 22, 1994SESE
K935968SPECTACLE FRAMESSae Biang Optical Co.Feb 22, 1994SESE
K934466SPECTACLE FRAMESAiress, Inc.Feb 22, 1994SESE
K935954OPTICAL FRAME COLLECTION NO. 2Frontier Novelty, Inc.Feb 16, 1994SESE
K935918SPECTACLE FRAMEKenmark Optical Co., Inc.Feb 16, 1994SESE
K935798MULTIPLE -SPECTACLE FRAMES/SUNGLASSESTae Kyung Optical Co., Inc.Feb 16, 1994SESE
K935729OPTICAL FRAMES AND/OR SUNGLASSESIvo Eyewear, Inc.Feb 16, 1994SESE
K935605SPECTACLE FRAMESSovereign Eyewear, Inc.Feb 16, 1994SESE
K930566OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASSE.B. Brown OpticiansFeb 16, 1994SESE
K935558SPECTACLE FRAME/EYEGLASS FRAMEModern Optical , Ltd.Jan 25, 1994SESE
K935107SPECTACLE FRAMESMr I'S Optical BoutiqueJan 25, 1994SESE
K934187SPECTACLE FRAMES AND SUNGLASSESWah Ming Optical Mfy. , Ltd.Jan 25, 1994SESE
K932821APEX OPTICAL IND. CO., EYE WEA MODELSApex Optical Ind. Co.Jan 25, 1994SESE
K930174GLASSES MOLASSESArthur F. Kozakowski, Jr.Jan 25, 1994SESE
K932439SPECTACLE FRAMESStyl-Rite Optics, Inc.Jan 3, 1994SESE
K934858FRAME SPECTACLEArno Intl., Inc.Dec 8, 1993SESE
K934797FINE OPTICSFine Optics, Inc.Dec 8, 1993SESE
K934463SPECTACLE FRAMEGood Bond Industrial Corp.Dec 8, 1993SESE
K934301SPECTACLE FRAMESGernot Lindner, Lunor-VertriebDec 8, 1993SESE
K930331SPECTACLE FRAMEAustralian Optical Co., Inc.Dec 8, 1993SESE
K934249TRACTION PRODUCTIONS SPECTACLE FRAMESTraction Productions, USANov 2, 1993SESE
K933529EYEGLASSES FRAMESVistula Assistance & Consulting BureauOct 20, 1993SESE
K930956SIGMA-BRILLEN (OR) MULTIPLESigma-BrillenOct 20, 1993SESE
K934082SPECTACLE FRAMESSouth American Optical, Inc.Oct 18, 1993SESE
K933991SPECTACLE FRAMESU.S. OpticalOct 18, 1993SESE
K933956ALDO'S OPTICAL FRAME COLLECTIONFrontier Novelty, Inc.Oct 18, 1993SESE
K933891SPECTACLE FRAMESEuro Frame Design, Inc.Oct 18, 1993SESE
K933865FRAMESHillman'S, the Eyecare Co., Inc.Oct 18, 1993SESE
K933809OPTO LINE SRLOptoline S.R.L.Oct 18, 1993SESE
K933765FRAME-SPECTACLEClearvision Optical Co., Inc.Oct 18, 1993SESE
K933453MULTIPLEFortuna Optical Factory , Ltd.Oct 13, 1993SESE
K933452MULTIPLETae Han Optical Ent.Oct 6, 1993SESE
K934198OPTIKOS SHAMI, INC. SPECTACLE FRAMESOptikos Shami, Inc.Oct 4, 1993SESE
K934033SPECTACLE FRAMESH.M.O. Optical, Inc.Oct 4, 1993SESE
K933733MARCHON/MARCOLIN EYEGLASSESMarchon Eyewear, Inc.Oct 1, 1993SESE
K933429MULTIPLESam Chung Optical Co., Ltd.Oct 1, 1993SESE
K932992SPECTACLE FRAMESVivid Optical Co., Ltd.Oct 1, 1993SESE
K932125OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSESVision Design Eyewear, Inc.Oct 1, 1993SESE
K931972FRAME - SPECTACLEEyetel Optics, Inc.Oct 1, 1993SESE
K931911BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMESBrillenerzeugung PombergerOct 1, 1993SESE
K933874SPECTACLE FRAMEDesigner FramesSep 20, 1993SESE
K933424STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAINZyloware Corp.Sep 20, 1993SESE
K933423STETSON/S.LOREN/LH.BAZAAR/G.VANDERBILT/P.BALMAINThunder Industries, Inc.Sep 20, 1993SESE
K933074SUNGLASSESP.T. Sun and Young Indonesia SunglassesSep 20, 1993SESE
K932773FRAMES, SPECTACLESDiaco, Inc.Sep 20, 1993SESE
K932772FRAMES, SPECTACLESOptical Designs and Sourcing, Inc.Sep 20, 1993SESE
K933436FRAME, SPECTACLEAoyama Optical Co., Ltd.Sep 9, 1993SESE
K933313SPECTACLE FRAMESSerrao Optical Intl., Inc.Sep 9, 1993SESE
K932999NEW STAR, TAE HAN OPTICALJ.B. Eyewear, Inc.Sep 9, 1993SESE
K932802SPECTACLE FRAMEInsight Optical Mfg. Co. of Florida, Inc.Sep 9, 1993SESE
K933280SPECTACLE FRAMESU.S. OpticalAug 31, 1993SESE
K932906SPECTACLE FRAMESU.S. Optics, Inc.Aug 31, 1993SESE
K932813FRAMES, SPECTACLERainbow Optics, Inc.Aug 31, 1993SESE
K930857MODISSA 90 S.R.L. SPECTACLE FRAMESModissa 90 SrlAug 25, 1993SESE
K931648SPECTACLE FRAMESEye Care Centers of America, Inc.Aug 5, 1993SESE
K933133SPECTACLE FRAMESSolitaire Designs, Ltd.Aug 2, 1993SESE
K931135ALTAIR EYEWEAR FRAMESAltair EyewearAug 2, 1993SESE
K930597SPECTACLE FRAMESVenis DI Alessandro VendrameAug 2, 1993SESE
K926157EYEGLASS FRAMERoi Factory Direct Frame Co.May 6, 1993SESE
K930561SOLSTAR BRILLENMODE SPECTACLE FRAMESSolstar Produktions GmbHMay 3, 1993SESE
K923884AUGUSTA VALENTINIRevue Intl.Mar 18, 1993SESE
K923500BEAUSOLEIL FRAMEOliver Peoples, Inc.Feb 16, 1993SESE
K921632INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASKLawrence Technologies, Inc.Dec 23, 1992SESE
K924232SPECTACLE FRAMESAptaker Co., Inc.Nov 5, 1992SESE
K923415DBA FOCAL CHANGE FRAMESFocal ChangeOct 13, 1992SESE
K922930OPTICAL FRAMESSt. Germain Eyewear Intl.Sep 17, 1992SESE
K922258SPECTACLE FRAMESBritish Optical Import Co.Sep 2, 1992SESE
K922687OPTHALMIC FRAMESOptique Forte , Ltd.Aug 31, 1992SESE
K922001SPECTACLE FRAMESOtego Optical, Inc.Jul 28, 1992SESE
K923177OPTICAL FRAMESA Toz Importing Co.Jul 27, 1992SESE
K920181OPTICAL FRAME A285, A210, B220, A215, A255, B220,Kentucky Optical Co.Apr 15, 1992SESE
K914975CABLE CAR SUNGLASSESCable Car SunglassesMar 31, 1992SESE
K920170SPECTACLE FRAMESciara Intl., Inc.Mar 11, 1992SESE
K920123SPECTACLE FRAMESPo-Le OptiksMar 6, 1992SESE
K915783S.A.A. EYE GLASS FRAMESYau Yee Optical Co., Ltd.Feb 27, 1992SESE
K914954SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.)Jsu Corp.Feb 27, 1992SESE
K914413SPECTACLE FRAMESMikado Ca.Dec 31, 1991SESE
K914614FRAMES (SPECTACLES) VARIOUS TYPESMatch Optical Co.Dec 30, 1991SESE
K914239FRAMES (SPECTACLES)Jane Fui Optical Co., Ltd.Dec 16, 1991SESE
K913046FRAMES (EYE GLASSES)Jiuh Chyi Ent. Co., Ltd.Aug 28, 1991SESE
K912034VENETO COLLECTIONAtlantic Optical Co., Inc.Aug 22, 1991SESE
K911332SPECTACLE FRAMEAustralian Optical Co., Inc.May 6, 1991SESE
K910951OPTHLAMIC FRAMESUnited Optical, SpaMay 6, 1991SESE
K910179OPTICAL FRAMEAustralian Optical Co., Inc.Apr 10, 1991SESE
K910134OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)Kentucky Optical Co.Mar 15, 1991SESE
K905183NEON RUBBER SUNGLASSESHa-Lo Advertising Specialties, Inc.Mar 4, 1991SESE
K910626J&B OPTICAL FRAMESJ & B Optical, Inc.Feb 26, 1991SESE
K904345FASHION FRAMESSunland Optical Co.Oct 11, 1990SESE
K904037PUMUCKL AND/OR DIETERLEPumucklSep 24, 1990SESE
K903949FRAME, SPECTACLEEureka Optics, Inc.Sep 10, 1990SESE
K903173LAURENT TARDYAcces Intl. EyewearAug 2, 1990SESE
K900732SPECTACLE FRAMESeiko Corp.Jun 20, 1990SESE
K897091FRAME, SPECTACLEPt Midas Surya Optical Co.Jun 14, 1990SESE
K897089WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES)Inno-Lite Co., Inc.Apr 23, 1990SESE
K895371FLEX EYEWEAR FRAMESFlex Eyewear, Inc.Sep 21, 1989SESE
K895300MULTIPLE MENTAL SPECTACLE FRAMESOptica Trade S.A.Sep 21, 1989SESE
K884272WOODEN SPECTACLE FRAMESWoodwaveDec 12, 1988SESE
K883100MULTIPLE SPECTACLE FRAMESMetal Optics U.S.A., Inc.Aug 25, 1988SESE
K883226OPTICAL OR EYEGLASS FRAMEUnique Optic , Ltd.Aug 24, 1988SESE
K873965FRAME, SPECTACLESwank Plus , Ltd.Apr 1, 1988SESE
K872607INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17Randolph Engineering, Inc.Oct 5, 1987SESE
K872062EYEDENTITY EYEWEARVitech Research C/O Johnsen, Manfredi & ThorpeJun 12, 1987SESE
K871689SPECTACLE FRAME - LORRAINERoseburg SAMay 29, 1987SESE
K871688SPECTACLE FRAME - DANIELLERoseburg SAMay 29, 1987SESE
K870179SPECTACLE FRAMES VARIOUS COLORS AND DESIGNSPolinelliApr 22, 1987SESE
K870220LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNSLem Srl.Apr 16, 1987SESE
K863862MILITARY PRESCRIPTION FRAMEHalo Optical Products, Inc.Oct 20, 1986SESE
K863182EYE BARRIERO.R. Concepts, Inc.Sep 3, 1986SESE
K863125EVE COLLECTION (EYEGLASS FRAME)Precision Lens CraftersSep 3, 1986SESE
K862503KOELN OPTIKSouth West Intl., Inc.Jul 11, 1986SESE
K862502MASUNAGA OPTICAL MANUFACTURINGSouth West Intl., Inc.Jul 11, 1986SESE
K860954SPECTACLES FRAMERoseburg SAMar 31, 1986SESE
K854343SIOMSouth West Intl., Inc.Nov 12, 1985SESE
K851661SOLEX & SAXON INT'L OPTICAL OF HONG KONGSouth West Intl., Inc.May 30, 1985SESE
K851130SPECTACLE FRAMENew Brillette A/SMay 30, 1985SESE
K851039EYEDENTITY EYEWEARVitech Research C/O Johnsen, Manfredi & ThorpeApr 1, 1985SESE
K844658SPECTABLE FRAME - PRODESIGN SUN CLUBPro Design Intl. ASDec 11, 1984SESE
K843123FRAME SPECTACLEVision Industries Corp.Oct 5, 1984SESE
K841908SPECTACLE FRAMESCosmas Optical USA , Ltd.Jun 7, 1984SESE
K833401OMYL -ARDE- SPECTACLE FRAMEI.J. Langleb , Ltd.Feb 21, 1984SESE
K831388GLASS FRAMES & COMPONENT PARTSAnamarJun 2, 1983SESE
K830413HANDPIECE SYSTEM I/AUxtra Corp.Apr 5, 1983SESE
K821391OPHTHALMIC EYEWEARNordic Eyewear, Inc.Jun 29, 1982SESE
K813156ULTRA-WIDE SAFETY SPECTACLE FRAMEZee Medical Products Co., Inc.Dec 14, 1981SESE
K810876SPECTACLE FRAMESFashionline Corp.Sep 21, 1981SESE
K810278EYEGLASS FRAMESCaesar Intl. DesignsApr 3, 1981SESE
K791112LIBCO 1,2,3, EYEGLASS FRAMESLibco Eyewear, Inc.Jun 15, 1979SESE
K790266SPECTACLE FRAMESAlva-Tech, Inc.Apr 4, 1979SESE
K772368SPECTACLE FRAME, OP-TITEDentsply Intl.Jan 30, 1978SESE
K772204EYEGLASS FRAMESLogo Paris, Inc.Jan 5, 1978SESE
K770221MEMLITE (PLASTIC EYEGLASS FRAMES)American Optical Corp.Feb 17, 1977SESE

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