Product Code: HQZ FDA class 1 21 CFR 886.5842

Frame, Spectacle

Ophthalmic

A Spectacle Frame is the structural component of a pair of eyeglasses, designed to hold corrective or protective ophthalmic lenses in the correct position in front of the wearer's eyes, encompassing the front piece, temples, nose pads, and associated hardware. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HQZ and is regulated under 21 CFR 886.5842, within the Ophthalmic medical specialty.

510(k)s
198
FEI Numbers
1189
Registration Numbers
1190
Unique Applicants
179
Years Active
19

Basic Information

Product Code
HQZ
Device Class
FDA class 1
Regulation Number
886.5842
Medical Specialty
Ophthalmic
Review Panel
OP
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 198 510(k) clearances via K numbers.

K Number Device Name
K952597 VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
K944313 SPECTACLE FRAME
K945770 OPTICAL FRAMES
K945392 SPECTACLE FRAME
K945176 SPECTACLE FRAME OR EYEGLASS FRAMES
K945350 FRAME, SPECTACLES
K945342 MAG-1 SPECTACLE FRAME
K945450 FRAME, SPECTACLE
K945340 SPECTACLE FRAMES OR EYEGLASS FRAMES
K945323 SPECTACLE FRAME
K945123 ARISTAR EYEWEAR, ESPRIT EYEWEAR
K944641 NIL
K944373 SPECTACLE FRAMES
K944160 SILHOUETTE, SUNLIMETED,ADIDAS
K943792 SPECTACLE FRAMES
K943641 SPECTACLE FRAME
K943561 SPECTACLE FRAME
K943913 MAX FRAME DESIGN
K943423 SPECTACLE FRAMES
K943753 FRAME SPECTACLE
K943567 FACONNABLE EYEWEAR
K943326 SPECTACLE FRAMES
K943507 WINK EYEWEAR
K943265 N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO
K943198 SPECTACLE FRAMES
K942897 OPTHALMIC WIPE
K942478 VISARD FRAMES
K943085 SPECTACLE FRAME
K943082 SPECTACLE FRAME
K942845 PERSOL, MOSCLHINO, AND GERALD GENTA
K943442 SPECTACLE FRAMES
K943236 OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX
K943086 SPECTACLE FRAME
K943083 SPECTACLE FRAME
K943084 SPECTACLE FRAME
K942750 SPECTACLE FRAMES
K942513 SEIKO EYEGLASS FRAME
K942463 FRAME, SPECTACLE
K942348 PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.
K941414 EYECOTECH CORP
K941463 SPECTACLE FRAMES, READING GLASSES
K941211 SPECTACLE FRAMES
K940733 SPECTACLE FRAMES (V.I.P. INT'L)
K941767 FRAMES - VARIOUS BRAND NAMES
K941602 SPECTACLE FRAMES
K941523 SPECTACLE FRAMES
K941307 SPECTACLE FRAMES
K940504 SPECTACLE FRAMES
K940977 SPECTACLE FRAMES
K941059 FRONTIER NOVELTY DAELIM OPTICAL FRAME
K941052 EYEGLASS SPECTACLE FRAMES VARIOUS COLLECTIONS
K940853 MORRISON FRAME, SPECTACLE
K940782 ARTSUN OPTICAL FRAME
K940077 SPECTACLE FRAMES (WING SHING OPTICAL)
K940411 EYEGLASS FRAMES (PLASTIC)
K940614 E.M.A.
K940560 SPECTACLE FRAMES
K940326 SPECTACLE FRAME
K935845 SPECTACLE FRAMES
K932612 DAELIM CORP. EYE WEAR MODEL
K940312 FRAME
K934570 SPECTACLE FRAMES
K940202 SPECTACLE FRAMES
K940201 PRESTIGE FRAMES
K940113 EYEGLASS FRAME
K936217 EYEGLASS FRAMES
K936149 ELITE COLLECTION
K936004 OPTICAL FRAMES
K935968 SPECTACLE FRAMES
K934466 SPECTACLE FRAMES
K935954 OPTICAL FRAME COLLECTION NO. 2
K935918 SPECTACLE FRAME
K935798 MULTIPLE -SPECTACLE FRAMES/SUNGLASSES
K935729 OPTICAL FRAMES AND/OR SUNGLASSES
K935605 SPECTACLE FRAMES
K930566 OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASS
K935558 SPECTACLE FRAME/EYEGLASS FRAME
K935107 SPECTACLE FRAMES
K934187 SPECTACLE FRAMES AND SUNGLASSES
K932821 APEX OPTICAL IND. CO., EYE WEA MODELS
K930174 GLASSES MOLASSES
K932439 SPECTACLE FRAMES
K934858 FRAME SPECTACLE
K934797 FINE OPTICS
K934463 SPECTACLE FRAME
K934301 SPECTACLE FRAMES
K930331 SPECTACLE FRAME
K934249 TRACTION PRODUCTIONS SPECTACLE FRAMES
K933529 EYEGLASSES FRAMES
K930956 SIGMA-BRILLEN (OR) MULTIPLE
K934082 SPECTACLE FRAMES
K933991 SPECTACLE FRAMES
K933956 ALDO'S OPTICAL FRAME COLLECTION
K933891 SPECTACLE FRAMES
K933865 FRAMES
K933809 OPTO LINE SRL
K933765 FRAME-SPECTACLE
K933453 MULTIPLE
K933452 MULTIPLE
K934198 OPTIKOS SHAMI, INC. SPECTACLE FRAMES
K934033 SPECTACLE FRAMES
K933733 MARCHON/MARCOLIN EYEGLASSES
K933429 MULTIPLE
K932992 SPECTACLE FRAMES
K932125 OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES
K931972 FRAME - SPECTACLE
K931911 BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMES
K933874 SPECTACLE FRAME
K933424 STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN
K933423 STETSON/S.LOREN/LH.BAZAAR/G.VANDERBILT/P.BALMAIN
K933074 SUNGLASSES
K932773 FRAMES, SPECTACLES
K932772 FRAMES, SPECTACLES
K933436 FRAME, SPECTACLE
K933313 SPECTACLE FRAMES
K932999 NEW STAR, TAE HAN OPTICAL
K932802 SPECTACLE FRAME
K933280 SPECTACLE FRAMES
K932906 SPECTACLE FRAMES
K932813 FRAMES, SPECTACLE
K930857 MODISSA 90 S.R.L. SPECTACLE FRAMES
K931648 SPECTACLE FRAMES
K933133 SPECTACLE FRAMES
K931135 ALTAIR EYEWEAR FRAMES
K930597 SPECTACLE FRAMES
K926157 EYEGLASS FRAME
K930561 SOLSTAR BRILLENMODE SPECTACLE FRAMES
K923884 AUGUSTA VALENTINI
K923500 BEAUSOLEIL FRAME
K921632 INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASK
K924232 SPECTACLE FRAMES
K923415 DBA FOCAL CHANGE FRAMES
K922930 OPTICAL FRAMES
K922258 SPECTACLE FRAMES
K922687 OPTHALMIC FRAMES
K922001 SPECTACLE FRAMES
K923177 OPTICAL FRAMES
K920181 OPTICAL FRAME A285, A210, B220, A215, A255, B220,
K914975 CABLE CAR SUNGLASSES
K920170 SPECTACLE FRAME
K920123 SPECTACLE FRAMES
K915783 S.A.A. EYE GLASS FRAMES
K914954 SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.)
K914413 SPECTACLE FRAMES
K914614 FRAMES (SPECTACLES) VARIOUS TYPES
K914239 FRAMES (SPECTACLES)
K913046 FRAMES (EYE GLASSES)
K912034 VENETO COLLECTION
K911332 SPECTACLE FRAME
K910951 OPTHLAMIC FRAMES
K910179 OPTICAL FRAME
K910134 OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)
K905183 NEON RUBBER SUNGLASSES
K910626 J&B OPTICAL FRAMES
K904345 FASHION FRAMES
K904037 PUMUCKL AND/OR DIETERLE
K903949 FRAME, SPECTACLE
K903173 LAURENT TARDY
K900732 SPECTACLE FRAME
K897091 FRAME, SPECTACLE
K897089 WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES)
K895371 FLEX EYEWEAR FRAMES
K895300 MULTIPLE MENTAL SPECTACLE FRAMES
K884272 WOODEN SPECTACLE FRAMES
K883100 MULTIPLE SPECTACLE FRAMES
K883226 OPTICAL OR EYEGLASS FRAME
K873965 FRAME, SPECTACLE
K872607 INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17
K872062 EYEDENTITY EYEWEAR
K871689 SPECTACLE FRAME - LORRAINE
K871688 SPECTACLE FRAME - DANIELLE
K870179 SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS
K870220 LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS
K863862 MILITARY PRESCRIPTION FRAME
K863182 EYE BARRIER
K863125 EVE COLLECTION (EYEGLASS FRAME)
K862503 KOELN OPTIK
K862502 MASUNAGA OPTICAL MANUFACTURING
K860954 SPECTACLES FRAME
K854343 SIOM
K851661 SOLEX & SAXON INT'L OPTICAL OF HONG KONG
K851130 SPECTACLE FRAME
K851039 EYEDENTITY EYEWEAR
K844658 SPECTABLE FRAME - PRODESIGN SUN CLUB
K843123 FRAME SPECTACLE
K841908 SPECTACLE FRAMES
K833401 OMYL -ARDE- SPECTACLE FRAME
K831388 GLASS FRAMES & COMPONENT PARTS
K830413 HANDPIECE SYSTEM I/A
K821391 OPHTHALMIC EYEWEAR
K813156 ULTRA-WIDE SAFETY SPECTACLE FRAME
K810876 SPECTACLE FRAMES
K810278 EYEGLASS FRAMES
K791112 LIBCO 1,2,3, EYEGLASS FRAMES
K790266 SPECTACLE FRAMES
K772368 SPECTACLE FRAME, OP-TITE
K772204 EYEGLASS FRAMES
K770221 MEMLITE (PLASTIC EYEGLASS FRAMES)

FEI Numbers

This FDA classification entry is associated with 1189 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1190 registration numbers. Click on an entry to view related FDA registrations.