Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- HJFMagnifier, Hand-Held, Low-Vision1Product Code
- HJGSystem, Reading, Television, Closed-Circuit1Product Code
- HJHLoupe, Binocular, Low Power1Product Code
- HJXReader, Prism, Ophthalmic1Product Code
- HJYReader, Bar, Ophthalmic1Product Code
- HJZCrutch, Ptosis1Product Code
- HKBTelescope, Hand-Held, Low-Vision1Product Code
- HKCSpectacle Microscope, Low-Vision1Product Code
- HKKTelescope, Spectacle, Low-Vision1Product Code
- HOISpectacle, Magnifying1Product Code
- HOTAid, Vision Image Intensification1Product Code
- HPEAid, Vision, Optical, Battery-Powered1Product Code
- HPFAid, Vision, Electronic, Ac-Powered1Product Code
- HPGAid, Vision, Electronic, Battery-Powered1Product Code
- HPIAid, Vision, Optical, Ac-Powered1Product Code
- HQDLens, Contact (Other Material) - Daily2Product Code
- HQGLens, Spectacle, Non-Custom (Prescription)1Product Code
- HQYSunglasses (Non-Prescription Including Photosensitive)1Product Code
- HQZFrame, Spectacle1Product Code
- K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW1Cleared 510(K)
- K944313SPECTACLE FRAME1Cleared 510(K)
- K945392SPECTACLE FRAME1Cleared 510(K)
- K945770OPTICAL FRAMES1Cleared 510(K)
- K945176SPECTACLE FRAME OR EYEGLASS FRAMES1Cleared 510(K)
- K945350FRAME, SPECTACLES1Cleared 510(K)
- K945342MAG-1 SPECTACLE FRAME1Cleared 510(K)
- K945450FRAME, SPECTACLE1Cleared 510(K)
- K945323SPECTACLE FRAME1Cleared 510(K)
- K945340SPECTACLE FRAMES OR EYEGLASS FRAMES1Cleared 510(K)
- K945123ARISTAR EYEWEAR, ESPRIT EYEWEAR1Cleared 510(K)
- K944641NIL1Cleared 510(K)
- K944373SPECTACLE FRAMES1Cleared 510(K)
- K944160SILHOUETTE, SUNLIMETED,ADIDAS1Cleared 510(K)
- K943792SPECTACLE FRAMES1Cleared 510(K)
- K943641SPECTACLE FRAME1Cleared 510(K)
- K943561SPECTACLE FRAME1Cleared 510(K)
- K943913MAX FRAME DESIGN1Cleared 510(K)
- K943423SPECTACLE FRAMES1Cleared 510(K)
- K943753FRAME SPECTACLE1Cleared 510(K)
- K943567FACONNABLE EYEWEAR1Cleared 510(K)
- K943326SPECTACLE FRAMES1Cleared 510(K)
- K943507WINK EYEWEAR1Cleared 510(K)
- K943265N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO1Cleared 510(K)
- K943198SPECTACLE FRAMES1Cleared 510(K)
- K942897OPTHALMIC WIPE1Cleared 510(K)
- K942478VISARD FRAMES1Cleared 510(K)
- K943082SPECTACLE FRAME1Cleared 510(K)
- K943085SPECTACLE FRAME1Cleared 510(K)
- K942845PERSOL, MOSCLHINO, AND GERALD GENTA1Cleared 510(K)
- K943442SPECTACLE FRAMES1Cleared 510(K)
- K943236OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX1Cleared 510(K)
- K943083SPECTACLE FRAME1Cleared 510(K)
- K943086SPECTACLE FRAME1Cleared 510(K)
- K943084SPECTACLE FRAME1Cleared 510(K)
- K942750SPECTACLE FRAMES1Cleared 510(K)
- K942513SEIKO EYEGLASS FRAME1Cleared 510(K)
- K942463FRAME, SPECTACLE1Cleared 510(K)
- K942348PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.1Cleared 510(K)
- K941414EYECOTECH CORP1Cleared 510(K)
- K941463SPECTACLE FRAMES, READING GLASSES1Cleared 510(K)
- K941211SPECTACLE FRAMES1Cleared 510(K)
- K940733SPECTACLE FRAMES (V.I.P. INT'L)1Cleared 510(K)
- K941767FRAMES - VARIOUS BRAND NAMES1Cleared 510(K)
- K941602SPECTACLE FRAMES1Cleared 510(K)
- K941523SPECTACLE FRAMES1Cleared 510(K)
- K941307SPECTACLE FRAMES1Cleared 510(K)
- K940504SPECTACLE FRAMES1Cleared 510(K)
- K940977SPECTACLE FRAMES1Cleared 510(K)
- K941059FRONTIER NOVELTY DAELIM OPTICAL FRAME1Cleared 510(K)
- K941052EYEGLASS SPECTACLE FRAMES VARIOUS COLLECTIONS1Cleared 510(K)
- K940853MORRISON FRAME, SPECTACLE1Cleared 510(K)
- K940782ARTSUN OPTICAL FRAME1Cleared 510(K)
- K940077SPECTACLE FRAMES (WING SHING OPTICAL)1Cleared 510(K)
- K940411EYEGLASS FRAMES (PLASTIC)1Cleared 510(K)
- K940614E.M.A.1Cleared 510(K)
- K940560SPECTACLE FRAMES1Cleared 510(K)
- K940326SPECTACLE FRAME1Cleared 510(K)
- K935845SPECTACLE FRAMES1Cleared 510(K)
- K932612DAELIM CORP. EYE WEAR MODEL1Cleared 510(K)
- K940312FRAME1Cleared 510(K)
- K934570SPECTACLE FRAMES1Cleared 510(K)
- K940202SPECTACLE FRAMES1Cleared 510(K)
- K940201PRESTIGE FRAMES1Cleared 510(K)
- K940113EYEGLASS FRAME1Cleared 510(K)
- K936217EYEGLASS FRAMES1Cleared 510(K)
- K936149ELITE COLLECTION1Cleared 510(K)
- K936004OPTICAL FRAMES1Cleared 510(K)
- K935968SPECTACLE FRAMES1Cleared 510(K)
- K934466SPECTACLE FRAMES1Cleared 510(K)
- K935954OPTICAL FRAME COLLECTION NO. 21Cleared 510(K)
- K935918SPECTACLE FRAME1Cleared 510(K)
- K935798MULTIPLE -SPECTACLE FRAMES/SUNGLASSES1Cleared 510(K)
- K935729OPTICAL FRAMES AND/OR SUNGLASSES1Cleared 510(K)
- K935605SPECTACLE FRAMES1Cleared 510(K)
- K930566OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASS1Cleared 510(K)
- K935558SPECTACLE FRAME/EYEGLASS FRAME1Cleared 510(K)
- K935107SPECTACLE FRAMES1Cleared 510(K)
- K934187SPECTACLE FRAMES AND SUNGLASSES1Cleared 510(K)
- K932821APEX OPTICAL IND. CO., EYE WEA MODELS1Cleared 510(K)
- K930174GLASSES MOLASSES1Cleared 510(K)
- K932439SPECTACLE FRAMES1Cleared 510(K)
- K934858FRAME SPECTACLE1Cleared 510(K)
- K934797FINE OPTICS1Cleared 510(K)
- K934463SPECTACLE FRAME1Cleared 510(K)
- K934301SPECTACLE FRAMES1Cleared 510(K)
- K930331SPECTACLE FRAME1Cleared 510(K)
- K934249TRACTION PRODUCTIONS SPECTACLE FRAMES1Cleared 510(K)
- K933529EYEGLASSES FRAMES1Cleared 510(K)
- K930956SIGMA-BRILLEN (OR) MULTIPLE1Cleared 510(K)
- K934082SPECTACLE FRAMES1Cleared 510(K)
- K933991SPECTACLE FRAMES1Cleared 510(K)
- K933956ALDO'S OPTICAL FRAME COLLECTION1Cleared 510(K)
- K933891SPECTACLE FRAMES1Cleared 510(K)
- K933865FRAMES1Cleared 510(K)
- K933809OPTO LINE SRL1Cleared 510(K)
- K933765FRAME-SPECTACLE1Cleared 510(K)
- K933453MULTIPLE1Cleared 510(K)
- K933452MULTIPLE1Cleared 510(K)
- K934198OPTIKOS SHAMI, INC. SPECTACLE FRAMES1Cleared 510(K)
- K934033SPECTACLE FRAMES1Cleared 510(K)
- K933733MARCHON/MARCOLIN EYEGLASSES1Cleared 510(K)
- K933429MULTIPLE1Cleared 510(K)
- K932992SPECTACLE FRAMES1Cleared 510(K)
- K932125OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES1Cleared 510(K)
- K931972FRAME - SPECTACLE1Cleared 510(K)
- K931911BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMES1Cleared 510(K)
- K933874SPECTACLE FRAME1Cleared 510(K)
- K933424STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN1Cleared 510(K)
- K933423STETSON/S.LOREN/LH.BAZAAR/G.VANDERBILT/P.BALMAIN1Cleared 510(K)
- K933074SUNGLASSES1Cleared 510(K)
- K932772FRAMES, SPECTACLES1Cleared 510(K)
- K932773FRAMES, SPECTACLES1Cleared 510(K)
- K933436FRAME, SPECTACLE1Cleared 510(K)
- K933313SPECTACLE FRAMES1Cleared 510(K)
- K932999NEW STAR, TAE HAN OPTICAL1Cleared 510(K)
- K932802SPECTACLE FRAME1Cleared 510(K)
- K933280SPECTACLE FRAMES1Cleared 510(K)
- K932906SPECTACLE FRAMES1Cleared 510(K)
- K932813FRAMES, SPECTACLE1Cleared 510(K)
- K930857MODISSA 90 S.R.L. SPECTACLE FRAMES1Cleared 510(K)
- K931648SPECTACLE FRAMES1Cleared 510(K)
- K933133SPECTACLE FRAMES1Cleared 510(K)
- K931135ALTAIR EYEWEAR FRAMES1Cleared 510(K)
- K930597SPECTACLE FRAMES1Cleared 510(K)
- K926157EYEGLASS FRAME1Cleared 510(K)
- K930561SOLSTAR BRILLENMODE SPECTACLE FRAMES1Cleared 510(K)
- K923884AUGUSTA VALENTINI1Cleared 510(K)
- K923500BEAUSOLEIL FRAME1Cleared 510(K)
- K921632INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASK1Cleared 510(K)
- K924232SPECTACLE FRAMES1Cleared 510(K)
- K923415DBA FOCAL CHANGE FRAMES1Cleared 510(K)
- K922930OPTICAL FRAMES1Cleared 510(K)
- K922258SPECTACLE FRAMES1Cleared 510(K)
- K922687OPTHALMIC FRAMES1Cleared 510(K)
- K922001SPECTACLE FRAMES1Cleared 510(K)
- K923177OPTICAL FRAMES1Cleared 510(K)
- K920181OPTICAL FRAME A285, A210, B220, A215, A255, B220,1Cleared 510(K)
- K914975CABLE CAR SUNGLASSES1Cleared 510(K)
- K920170SPECTACLE FRAME1Cleared 510(K)
- K920123SPECTACLE FRAMES1Cleared 510(K)
- K915783S.A.A. EYE GLASS FRAMES1Cleared 510(K)
- K914954SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.)1Cleared 510(K)
- K914413SPECTACLE FRAMES1Cleared 510(K)
- K914614FRAMES (SPECTACLES) VARIOUS TYPES1Cleared 510(K)
- K914239FRAMES (SPECTACLES)1Cleared 510(K)
- K913046FRAMES (EYE GLASSES)1Cleared 510(K)
- K912034VENETO COLLECTION1Cleared 510(K)
- K911332SPECTACLE FRAME1Cleared 510(K)
- K910951OPTHLAMIC FRAMES1Cleared 510(K)
- K910179OPTICAL FRAME1Cleared 510(K)
- K910134OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)1Cleared 510(K)
- K905183NEON RUBBER SUNGLASSES1Cleared 510(K)
- K910626J&B OPTICAL FRAMES1Cleared 510(K)
- K904345FASHION FRAMES1Cleared 510(K)
- K904037PUMUCKL AND/OR DIETERLE1Cleared 510(K)
- K903949FRAME, SPECTACLE1Cleared 510(K)
- K903173LAURENT TARDY1Cleared 510(K)
- K900732SPECTACLE FRAME1Cleared 510(K)
- K897091FRAME, SPECTACLE1Cleared 510(K)
- K897089WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES)1Cleared 510(K)
- K895371FLEX EYEWEAR FRAMES1Cleared 510(K)
- K895300MULTIPLE MENTAL SPECTACLE FRAMES1Cleared 510(K)
- K884272WOODEN SPECTACLE FRAMES1Cleared 510(K)
- K883100MULTIPLE SPECTACLE FRAMES1Cleared 510(K)
- K883226OPTICAL OR EYEGLASS FRAME1Cleared 510(K)
- K873965FRAME, SPECTACLE1Cleared 510(K)
- K872607INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-171Cleared 510(K)
- K872062EYEDENTITY EYEWEAR1Cleared 510(K)
- K871689SPECTACLE FRAME - LORRAINE1Cleared 510(K)
- K871688SPECTACLE FRAME - DANIELLE1Cleared 510(K)
- K870179SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS1Cleared 510(K)
- K870220LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS1Cleared 510(K)
- K863862MILITARY PRESCRIPTION FRAME1Cleared 510(K)
- K863182EYE BARRIER1Cleared 510(K)
- K863125EVE COLLECTION (EYEGLASS FRAME)1Cleared 510(K)
- K862502MASUNAGA OPTICAL MANUFACTURING1Cleared 510(K)
- K862503KOELN OPTIK1Cleared 510(K)
- K860954SPECTACLES FRAME1Cleared 510(K)
- K854343SIOM1Cleared 510(K)
- K851661SOLEX & SAXON INT'L OPTICAL OF HONG KONG1Cleared 510(K)
- K851130SPECTACLE FRAME1Cleared 510(K)
- K851039EYEDENTITY EYEWEAR1Cleared 510(K)
- K844658SPECTABLE FRAME - PRODESIGN SUN CLUB1Cleared 510(K)
- K843123FRAME SPECTACLE1Cleared 510(K)
- K841908SPECTACLE FRAMES1Cleared 510(K)
- K833401OMYL -ARDE- SPECTACLE FRAME1Cleared 510(K)
- K831388GLASS FRAMES & COMPONENT PARTS1Cleared 510(K)
- K830413HANDPIECE SYSTEM I/A1Cleared 510(K)
- K821391OPHTHALMIC EYEWEAR1Cleared 510(K)
- K813156ULTRA-WIDE SAFETY SPECTACLE FRAME1Cleared 510(K)
- K810876SPECTACLE FRAMES1Cleared 510(K)
- K810278EYEGLASS FRAMES1Cleared 510(K)
- K791112LIBCO 1,2,3, EYEGLASS FRAMES1Cleared 510(K)
- K790266SPECTACLE FRAMES1Cleared 510(K)
- K772368SPECTACLE FRAME, OP-TITE1Cleared 510(K)
- K772204EYEGLASS FRAMES1Cleared 510(K)
- K770221MEMLITE (PLASTIC EYEGLASS FRAMES)1Cleared 510(K)
- HRCSterilizer, Soft-Lens, Thermal, Battery-Powered2Product Code
- HRDSterilizer, Soft-Lens, Thermal, Ac-Powered2Product Code
- HRLUnit, Beta, Radiation, Ophthalmic2Product Code
- KYEInserter/Remover Contact Lens1Product Code
- LPLLenses, Soft Contact, Daily Wear2Product Code
- LPMLenses, Soft Contact, Extended Wear3Product Code
- LPNAccessories, Soft Lens Products2Product Code
- LRXCase, Contact Lens2Product Code
- LYLAccessories, Solution, Ultrasonic Cleaners For Lenses2Product Code
- MMLWeights, Eyelid, External2Product Code
- MRCProducts, Contact Lens Care, Rigid Gas Permeable2Product Code
- MUWLens, Contact (Orthokeratology)2Product Code
- MVNLens, Contact, (Disposable)2Product Code
- MWLLens, Contact (Rigid Gas Permeable), Extended Wear3Product Code
- MZDSystem, In-Office Tinting, Contact Lenses2Product Code
- NAILens, Prescription, Color Deficiency1Product Code
- NCBWeights, Eyelid, Implantable2Product Code
- NCZLens, Contact, For Color Vision Deficiency2Product Code
- NICLens, Contact, For Reading Discomfort2Product Code
- NJHLens, Spectacle (Prescription), For Reading Discomfort1Product Code
- NUULens, Contact, Orthokeratology, Overnight3Product Code
- ORZEyelid Thermal Pulsation System2Product Code
- PICOral Electronic Vision Aid2Product Code
- PLXTear Duct Occluder1Product Code
- PQJIntranasal Electrostimulation Device2Product Code
- QBRIntranasal Electrostimulation Device For Dry Eye Symptoms2Product Code
- QIUIntense Pulsed Light Device For Managing Dry Eye2Product Code
- QKVElectromechanical Tear Stimulator2Product Code
- QMMHydrophilic Re-Coating Solution2Product Code
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K872607
- 510(k) Type
- Traditional
- Applicant
- RANDOLPH ENGINEERING, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/5/1987
- Days to Decision
- 91 days