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
- K974852NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K974860NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K974861NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K974511SUNGLASSES1Cleared 510(K)
- K974441SUNGLASSES1Cleared 510(K)
- K974414MULTI1Cleared 510(K)
- K973528SUNGLASSES1Cleared 510(K)
- K974179NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K974045VENNETO1Cleared 510(K)
- K973934SUNGLASSES1Cleared 510(K)
- K973526SUNGLASSES1Cleared 510(K)
- K973490SUNGLASSES1Cleared 510(K)
- K973407SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K973016NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS1Cleared 510(K)
- K972850SUNGLASSES1Cleared 510(K)
- K972717RUFF WORK EYEGEAR1Cleared 510(K)
- K972590NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES1Cleared 510(K)
- K972490D'ARC EYE CARE SUNGLASSES1Cleared 510(K)
- K972416MOMO DESIGN OR MOMO1Cleared 510(K)
- K972362FOVS, BRILLARTE, ETC...1Cleared 510(K)
- K971385SUNGLASSES1Cleared 510(K)
- K971462SUNGLASSES1Cleared 510(K)
- K971384(BRAND NAME)1Cleared 510(K)
- K972246SPECTACLE FRAMES (NON-PRESCRIPTION)1Cleared 510(K)
- K972194RIVIERA SUNGLASS4ES1Cleared 510(K)
- K972014SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K971644CEBE1Cleared 510(K)
- K971875OPTIM-EYES 4501Cleared 510(K)
- K971707SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K971087SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)1Cleared 510(K)
- K970816GLARE WARE1Cleared 510(K)
- K971551DUQIAO1Cleared 510(K)
- K971495PATHFINDER SUNGLASSES1Cleared 510(K)
- K971412SUNGLASSES1Cleared 510(K)
- K970699AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES1Cleared 510(K)
- K971327UNIKA1Cleared 510(K)
- K971326ARROW COMPANY1Cleared 510(K)
- K971249GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN1Cleared 510(K)
- K971104CLASSIC MATCH1Cleared 510(K)
- K970944BARAKKA, INFERNO, STERLING, AND/OR ONE1Cleared 510(K)
- K970895CUSTOM OPTICAL SUNGLASS FRAMES1Cleared 510(K)
- K970759SOLAR SPECS1Cleared 510(K)
- K970476HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K970454LAXIMA INTERNATIONAL LIMITED SUNGLASSES1Cleared 510(K)
- K970315EVEREST SUNGLASSES1Cleared 510(K)
- K970744STYLE EYES OPTICS1Cleared 510(K)
- K970538VICTORY EYEWEAR CO1Cleared 510(K)
- K965125DAKOTA SMITH, NICOLE MILLER SUNGLASSES1Cleared 510(K)
- K965170ROCCOBAROCCO & PRO-DYNAMIX1Cleared 510(K)
- K970101JAMES ALEX SUNGLASSES1Cleared 510(K)
- K965021NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K964943SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K964744SENNA1Cleared 510(K)
- K964564SUNGLASSES1Cleared 510(K)
- K964366EAGLE EYES1Cleared 510(K)
- K964505GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES1Cleared 510(K)
- K964316PLASTIC SUNGLASSES1Cleared 510(K)
- K964429SUNGLASSES OR MULTIPLE1Cleared 510(K)
- K964082SUNGLASSES1Cleared 510(K)
- K964058SPENSER SUNGLASSES AND SPORT SUNGLASSES1Cleared 510(K)
- K964413SUNGLASSES(NON-PRESCRIPTION)1Cleared 510(K)
- K963968FLYWAY1Cleared 510(K)
- K963955DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS1Cleared 510(K)
- K963890VARIOUS SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K963630C.O.L.D.A.1Cleared 510(K)
- K963083LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES1Cleared 510(K)
- K963284RAVEN EYE- EYE WEAR (SUNGLASSES)1Cleared 510(K)
- K962940RAVEN EYE, INC.- EYE WEAR1Cleared 510(K)
- K962279ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES1Cleared 510(K)
- K963059SUNQUEST INTERNATIONAL1Cleared 510(K)
- K963075FITO DIDO1Cleared 510(K)
- K962912MARCELLA CARAN1Cleared 510(K)
- K962287EAGLE EYES SUNGLASSES1Cleared 510(K)
- K962775SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K962725SOMA1Cleared 510(K)
- K962636SUNGLASSES, GAUDI SUN LINE1Cleared 510(K)
- K962478(BRAND NAME) SUNGLASS FRAMES1Cleared 510(K)
- K962382XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.1Cleared 510(K)
- K962298CENTER OPTICAL GLASSES1Cleared 510(K)
- K962412NIKE V8 AND NIKE V121Cleared 510(K)
- K962310NON-GENERIC1Cleared 510(K)
- K962436SUNGLASSES1Cleared 510(K)
- K962169MAGNETO EYEWEAR1Cleared 510(K)
- K962107IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG51Cleared 510(K)
- K961990NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K961146SUNGLASSES1Cleared 510(K)
- K960953SUNGLASSES1Cleared 510(K)
- K960818SUNGLASSES1Cleared 510(K)
- K960668MISTRAL SUNGLASSES1Cleared 510(K)
- K961746CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY1Cleared 510(K)
- K961286STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES1Cleared 510(K)
- K954419SPECTACLE FRAMES/SUNGLASSES1Cleared 510(K)
- K961603SUN CLIP1Cleared 510(K)
- K961523TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES1Cleared 510(K)
- K960735EVERGLORY SUNGLASSES1Cleared 510(K)
- K943145AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE1Cleared 510(K)
- K961268OAKLEY, INC SUNGLASSES1Cleared 510(K)
- K961128SUNGLASSES1Cleared 510(K)
- K961117VISARD SUNGLASSES1Cleared 510(K)
- K961034SUNGLASSES1Cleared 510(K)
- K960798D & K SUNGLASSES1Cleared 510(K)
- K961035US-HOLO SUNGLASSES1Cleared 510(K)
- K960950FRANCO SORDELLI SUNGLASSES1Cleared 510(K)
- K960890SUNGLASSES OR MULTIPLE1Cleared 510(K)
- K960650NON PRESCRIPTION SUN GLASSES1Cleared 510(K)
- K960797D & K SUNGLASSES1Cleared 510(K)
- K960786FABRIS LAN SUNGLASSES1Cleared 510(K)
- K960573SUNGLASSES/EYEGLASS FRAMES1Cleared 510(K)
- K960628LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE ZONE1Cleared 510(K)
- K960530ARNET OR ARNETTE1Cleared 510(K)
- K955933BUFFARD CREATION (SUNGLASSES)1Cleared 510(K)
- K960289JAMES KOREA OPTICAL FRAMES & SUNGLASSES1Cleared 510(K)
- K955695PLASTIC FRAME, METAL FRAME, OPTICAL1Cleared 510(K)
- K955441ZONG RONG SUNGLASSES1Cleared 510(K)
- K955287ZONG RONG SUNGLASSES1Cleared 510(K)
- K955572SUNGLASSES WITH IMPACT RESISTANT LENSES1Cleared 510(K)
- K954659MOONSHADES SUNGLASSES1Cleared 510(K)
- K955611KMANZ II1Cleared 510(K)
- K955539UNISUN1Cleared 510(K)
- K955127HANYANG SUNGLASSES1Cleared 510(K)
- K955290KUO & YANG SUNGLASSES1Cleared 510(K)
- K954639SUNGLASSES1Cleared 510(K)
- K954636BLINDE OPTICS1Cleared 510(K)
- K954393SINCLAIR NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K953808CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K953627NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K953744AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES1Cleared 510(K)
- K951757DRIVING GLASSES1Cleared 510(K)
- K954173SPECTACLE SUN GLASSES (NON PRESCRIPTION)1Cleared 510(K)
- K954075YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.1Cleared 510(K)
- K953920REVERT SUNGLASSES & POLAR SUNGLASSES1Cleared 510(K)
- K953947SUNGLASSES1Cleared 510(K)
- K953782NIL1Cleared 510(K)
- K953989SUNGLASSES1Cleared 510(K)
- K952963SUNGLASSES & SPORT SUNGLASSES1Cleared 510(K)
- K952438SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)1Cleared 510(K)
- K953629SPECTACLE SUNGLASSES(NON-PRESCRIPTION)1Cleared 510(K)
- K951801MING-YA OPTICAL INDUSTRIALCO., LTD.1Cleared 510(K)
- K941084SUNGLASSES1Cleared 510(K)
- K952734HENNERT SA1Cleared 510(K)
- K953473SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K953413OPTX 20/201Cleared 510(K)
- K952939ROYAL FLASH1Cleared 510(K)
- K952758GOUVERNEUR AUDIGIER1Cleared 510(K)
- K952258HURRICANE1Cleared 510(K)
- K953260SUNGLASSES1Cleared 510(K)
- K953245NYX GOLF VISION SYSTEM1Cleared 510(K)
- K953092FOSTER GRANT NON PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K951979SUNGLASSES1Cleared 510(K)
- K951551FREDEIC BEAUSOCEIL1Cleared 510(K)
- K953002METAL FRAM WITH POLYCARBONATE LENS1Cleared 510(K)
- K952890SUNGLASSES1Cleared 510(K)
- K951815SUNGLASSES1Cleared 510(K)
- K951992FAIRY WORLD INC1Cleared 510(K)
- K940324SPECTACLE SUN GLASSES1Cleared 510(K)
- K950807SUNBLOCKER SUNGLASSES1Cleared 510(K)
- K951168CRYSTAL1Cleared 510(K)
- K951438BENSON AND ASHLEY1Cleared 510(K)
- K951131SUNGLASSES, NONPRESCRIPTION1Cleared 510(K)
- K951008POWER RANGERS SUNGLASSES1Cleared 510(K)
- K951504SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K940724NONE-GENERIC1Cleared 510(K)
- K951439SUNGLASSES1Cleared 510(K)
- K942142FRINDLEY ENTERPRISE CO1Cleared 510(K)
- K940725NONE-GENERIC1Cleared 510(K)
- K945808RUNNING SUNGLASSES1Cleared 510(K)
- K951209SUNGLASSES1Cleared 510(K)
- K950083MULTIPLE1Cleared 510(K)
- K951080SUNGLASSES1Cleared 510(K)
- K950922CHAMP INTERNATIONAL CORP.1Cleared 510(K)
- K950938HILTON, BENTLY SET, SENATOR, MAYFAIR MATCH AND MONSIUR1Cleared 510(K)
- K945922NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K950609ORVIS KEY WEST SUNGLASSES1Cleared 510(K)
- K950519SILHOUETTE SUNLIMITED ADIDAS1Cleared 510(K)
- K950526SUNGLASSES1Cleared 510(K)
- K945895METAL FRAME, PLASTIC FRAME1Cleared 510(K)
- K950456MARTIN SUNGLASSES1Cleared 510(K)
- K950391NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K950720KBTC1Cleared 510(K)
- K950226CHILDREN'S SUNGLASSES1Cleared 510(K)
- K950374FOSSIL PARTNERS, L.P. (FOSSIL)1Cleared 510(K)
- K950252CHAMPRO/UNITED ATHLETIC1Cleared 510(K)
- K950193PHILIPPE CHARRIOL1Cleared 510(K)
- K942020SUNGLASSES1Cleared 510(K)
- K946381SUNGLASSES1Cleared 510(K)
- K941267NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K941266NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K950079SUNGLASSES1Cleared 510(K)
- K945680METZLER, ALPINA, MENRAD, POLICE, L. BIAGIOTTI, CFF, R. LAUREN, POLO, NEOMETAL, L'AMY, NEOSTYLE ETC.1Cleared 510(K)
- K945528SUNGLASSES AND SPORT SUNGLASSES1Cleared 510(K)
- K946092AVON SUNNY DAYS SUNGLASSES1Cleared 510(K)
- K946091AVON SUNNY DAYS SUNGLASSES1Cleared 510(K)
- K946004FI, GORDY TOY, WELLJOY AND OTHERS1Cleared 510(K)
- K946256SUNGLASSES1Cleared 510(K)
- K946231EYE COOLER1Cleared 510(K)
- K946132PROWAY1Cleared 510(K)
- K945920SUNGLASSES1Cleared 510(K)
- K945925EYEWEAR/SPECTACLES1Cleared 510(K)
- K945988SUNGLASSES1Cleared 510(K)
- K945917POWERR RANGERS SUNGLASSES1Cleared 510(K)
- K945823POWER RANGERS SUNGLASSES1Cleared 510(K)
- K944568SUNGLASSES1Cleared 510(K)
- K945840BUNNY SUNGLASSES1Cleared 510(K)
- K945819SUNGLASSES1Cleared 510(K)
- K945817SUNGLASSES1Cleared 510(K)
- K945818SUNGLASSES1Cleared 510(K)
- K945735SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSES1Cleared 510(K)
- K945683VETTA LIGHTWEIGHT CYCLING EYEWEAR1Cleared 510(K)
- K945147PECTACLE FRAMES AND/OR SUNGLASSES1Cleared 510(K)
- K944398SUNGLASSES1Cleared 510(K)
- K944235ADVANCE CORP. SUNGLASSES1Cleared 510(K)
- K945341MULTIPLE1Cleared 510(K)
- K945282MULTIPLE1Cleared 510(K)
- K945006COLLEGIATE COLORS1Cleared 510(K)
- K945249RED DRAGON CORPORATION1Cleared 510(K)
- K945122ARISTAR EYEWEAR, ESPRIT EYEWEAR1Cleared 510(K)
- K944996NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K945036BRIGHTEN1Cleared 510(K)
- K944915AXIOM, SUNFAST1Cleared 510(K)
- K944312SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR1Cleared 510(K)
- K941437UNBREAKABLE LENS1Cleared 510(K)
- K944644SUNGLASSES AND SPECTACLE FRAMES1Cleared 510(K)
- K944526OPTICAL FRAMES AND SUNGLASSES1Cleared 510(K)
- K944341ROYAL PLASTIC SUNGLASSES1Cleared 510(K)
- K945001SUNGLASSES1Cleared 510(K)
- K944484KODI OPTICAL CO., LTD. SUNGLASSES1Cleared 510(K)
- K944783SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES1Cleared 510(K)
- K944394SUNGLASSES1Cleared 510(K)
- K944328TONKA BOYS SUNGLASSES1Cleared 510(K)
- K944281SUNGLASSES1Cleared 510(K)
- K942011SUNGLASSES1Cleared 510(K)
- K941006SUNGLASSES1Cleared 510(K)
- K944108NIL1Cleared 510(K)
- K944109NIL1Cleared 510(K)
- K944026MIRAGE EYEWEAR INC.1Cleared 510(K)
- K943963NIL1Cleared 510(K)
- K943640SUNGLASS CLIP1Cleared 510(K)
- K943562SUNGLASSES1Cleared 510(K)
- K943296ILO MADE IN ITALY; GARBO HAND FINISHED ITALY1Cleared 510(K)
- K940421SUNGLASSES1Cleared 510(K)
- K943840(BRAND NAME0 MONDAIN1Cleared 510(K)
- K943039SPECTACLE FRAMES1Cleared 510(K)
- K942322SUNGLASSES1Cleared 510(K)
- K941726SUNGLASSES1Cleared 510(K)
- K943912SUNGLASSES1Cleared 510(K)
- K943677SUNGLASSES1Cleared 510(K)
- K942531SUNGLASSES1Cleared 510(K)
- K943405STYLE I WRAPPER SUNGLASSES1Cleared 510(K)
- K943377SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K943501SUNGLASSES AND SPORT SUNGLASSES1Cleared 510(K)
- K940969SUNGLASSES1Cleared 510(K)
- K943263NIL1Cleared 510(K)
- K943609SUNGLASSES1Cleared 510(K)
- K943568FACONNABLE EYEWEAR (SUNGLASSES)1Cleared 510(K)
- K935264CHILDREN'S SUNGLASSES1Cleared 510(K)
- K943352SPOMA INTERNATIONAL CORPORATION1Cleared 510(K)
- K942754SUNGLASSES1Cleared 510(K)
- K943328EVERYTHING KIDS1Cleared 510(K)
- K943161ORVIS DRIVING GLASSES1Cleared 510(K)
- K941148SUNGLASSES1Cleared 510(K)
- K940561SUNGLASSES1Cleared 510(K)
- K936125SPECTACLE FRAMES, SUNGLASSES1Cleared 510(K)
- K943443SUNGLASSES1Cleared 510(K)
- K943131ORVIS POLARIZED BI-FOCALS1Cleared 510(K)
- K942951ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS1Cleared 510(K)
- K941929SUNGLASSES1Cleared 510(K)
- K941540SUNGLASSES1Cleared 510(K)
- K943202EASSUN HI-TECH OPTICS1Cleared 510(K)
- K942932GLADIATOR1Cleared 510(K)
- K926564OPTICAL FRAMES AND SUNGLASSES1Cleared 510(K)
- K942952ORVIS WORLD FINEST POLARIZED CLIP ONS1Cleared 510(K)
- K942755NIL1Cleared 510(K)
- K942673NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K942067SAM SUNG OPTICAL1Cleared 510(K)
- K942038SUNGLASSES1Cleared 510(K)
- K942037SUNGLASSES1Cleared 510(K)
- K942001SUNGLASSES1Cleared 510(K)
- K941874SUNGLASSES1Cleared 510(K)
- K941581HAPPY EYES OPTICAL CO. SUNGLASSES1Cleared 510(K)
- K940925SUNGLASSES1Cleared 510(K)
- K940372SUNGLASSES, SPECTACLE FRAMES1Cleared 510(K)
- K932484MARS SUNGLASSES1Cleared 510(K)
- K942783NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K942119U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES1Cleared 510(K)
- K936072NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K942652SCHOOL MASCOT EYEWEAR1Cleared 510(K)
- K942588NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K942500SUNGLASSES TOKYO BAY1Cleared 510(K)
- K941555SUNGLASSES/VARIOUS COLLECTIONS1Cleared 510(K)
- K941538SUNGLASSES1Cleared 510(K)
- K941441NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K941047WESTERN TRADING CO1Cleared 510(K)
- K941053NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES1Cleared 510(K)
- K940924SUNGLASSES1Cleared 510(K)
- K940626CLEVER OPTICAL INDUSTRIES LTD1Cleared 510(K)
- K940628JIHN MEI OPTICAL CO.1Cleared 510(K)
- K940625CHEN SHUENG ENTERPRISE CO.1Cleared 510(K)
- K940629YEOU NAN SUNGLASSES CO1Cleared 510(K)
- K940627WENZHOU IMPORT AND EXPORT CORP1Cleared 510(K)
- K940488CHEN-HERSIN SUNGLASSES1Cleared 510(K)
- K925596NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K941910SUNGLASSES1Cleared 510(K)
- K941785SUNGLASSES1Cleared 510(K)
- K942039SUNGLASSES1Cleared 510(K)
- K940592SUNGLASSES1Cleared 510(K)
- K941061SUNGLASSES1Cleared 510(K)
- K940923SUNGLASSES1Cleared 510(K)
- K942237SUNGLASSES1Cleared 510(K)
- K941687CHILDREN'S SUNGLASSES1Cleared 510(K)
- K941432NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K941119XIAMEN DYNASTY OPTICAL CORP1Cleared 510(K)
- K940659SUNGLASSES1Cleared 510(K)
- K942375SUNGLASSES1Cleared 510(K)
- K941875SUNGLASSES1Cleared 510(K)
- K941873SUNGLASSES1Cleared 510(K)
- K941751SUNGLASSES1Cleared 510(K)
- K941576SPECTACLE FRAMES/SUNGLASSES1Cleared 510(K)
- K941296SUNGLASSES1Cleared 510(K)
- K940947CROWN,SKI OPTIC SUNGLASSES1Cleared 510(K)
- K940850SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K940831SKI VECTOR NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K940741MOUNTAIN SHADES -NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K940740SKI VECTOR NON PRECRIPTION SUNGLASSES1Cleared 510(K)
- K934576SUNGLASSES1Cleared 510(K)
- K940958NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K941930SUNGLASSES1Cleared 510(K)
- K941786SUNGLASSES1Cleared 510(K)
- K941732SUNGLASSES1Cleared 510(K)
- K941668SUNGLASSES1Cleared 510(K)
- K941682COOL KIDS BEADS AND SHADES1Cleared 510(K)
- K941638SUNGLASSES1Cleared 510(K)
- K941629SUNGLASSES1Cleared 510(K)
- K941590SUNGLASSES1Cleared 510(K)
- K941502SUNGLASSES1Cleared 510(K)
- K941410CHIN HSIEU CHENG1Cleared 510(K)
- K941380SUNGLASSES1Cleared 510(K)
- K941369AVON CAT SUNGLASSES1Cleared 510(K)
- K941340BORRION ENTERPRISE CO1Cleared 510(K)
- K941338CHANG CHENG CHUNG1Cleared 510(K)
- K941280SUNGLASSES (NON PRESCRIPTION)1Cleared 510(K)
- K941186NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K941060ALPINA EYEWEAR1Cleared 510(K)
- K940945SUNGLASSES1Cleared 510(K)
- K940943SUNGLASSES1Cleared 510(K)
- K940728NONE-GENERIC1Cleared 510(K)
- K94070586 HQY SUNGLASSES1Cleared 510(K)
- K940609TOUCH CORP1Cleared 510(K)
- K940311SUNGLASSES AND SPORT SUNGLASSES1Cleared 510(K)
- K935422SUNLOVERS, CHARLES JOURDAN, COURREGES SUNGLASSES1Cleared 510(K)
- K934659SUNGLASS1Cleared 510(K)
- K941680SUNGLASSES1Cleared 510(K)
- K941529SUNGLASSES1Cleared 510(K)
- K941442I CARE1Cleared 510(K)
- K941415FITIPALDI DRIVING SUNGLASSES1Cleared 510(K)
- K941695SUNGLASSES1Cleared 510(K)
- K941297YUNG HSU OPTICAL WORKS CO1Cleared 510(K)
- K941138SG-22 SUNGLASSES1Cleared 510(K)
- K941077SUNGLASSES1Cleared 510(K)
- K940990SUNGLASSES1Cleared 510(K)
- K936103CROWN SUNGLASSES1Cleared 510(K)
- K935037NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K940946GUANGZHOU DASHIN OPTICS ENT.1Cleared 510(K)
- K940250NEW EYES EYEGLASS FRAME1Cleared 510(K)
- K935943KING'S SUNGLASS CORP.1Cleared 510(K)
- K941147SPLASHMASTER OC EYE AND FACE PROTECTIVE PRODUCTS1Cleared 510(K)
- K941076SUNGLASSES AND SPORT SUNGLASSES1Cleared 510(K)
- K941055NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K941051SPECTACLE FRAMES/SUNGLASSES1Cleared 510(K)
- K940846NIL1Cleared 510(K)
- K940827REWINNER ENT H.K. BRANCH NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K940730YON'S JAY ENTERPRISE CO1Cleared 510(K)
- K940613E.M.A.1Cleared 510(K)
- K940182SUNGLASSES1Cleared 510(K)
- K932844SUNGLASSES1Cleared 510(K)
- K940956RIO EYEWEAR, PANAMA JACK ENVIRONMENT OPTICS, AND PARADISE RESORT EYEWEAR1Cleared 510(K)
- K940944DAY SUN INDUSTRIAL CORP1Cleared 510(K)
- K940828WENZHOU IMPORT/EXPORT CORP. NON-PRESCRIPT SUNGLASSES1Cleared 510(K)
- K940806NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K940830REWINNER ENT CO. LTD. NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K940726NONE-GENERIC1Cleared 510(K)
- K940612E.M.A.1Cleared 510(K)
- K934407SUNGLASS GALLERY INC. SUNGLASS1Cleared 510(K)
- K940778SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K940420TALKING RAP SHADES1Cleared 510(K)
- K935974SPECTACLE FRAMES AND SUNGLASSES1Cleared 510(K)
- K935734SUNGLASSES1Cleared 510(K)
- K935700JIN CHANG SUNGLASSES1Cleared 510(K)
- K934461NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K935099SUNGLASSES1Cleared 510(K)
- K940354ORVIS MARQUESAS FISHING GLASSES1Cleared 510(K)
- K940292ORVIS RIVER GUIDE GLASSES1Cleared 510(K)
- K934567SUNGLASSES (NON-PERSCRIPTION)1Cleared 510(K)
- K936027SPORTS RADIO SUNGLASSES1Cleared 510(K)
- K935920SPECTACLE FRAME1Cleared 510(K)
- K936146SPECTACLE FRAMES1Cleared 510(K)
- K936218SEE MONSTERS SUNGLASSES1Cleared 510(K)
- K936033SUNGLASSES1Cleared 510(K)
- K935969SPECTACLE FRAMES1Cleared 510(K)
- K935903SPLASHMASTER PRESCRIPTION EYEWEAR1Cleared 510(K)
- K935114SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K935764NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K933819SUNGLASSES1Cleared 510(K)
- K931497SUNGLASSES1Cleared 510(K)
- K931512SUNGLASSES1Cleared 510(K)
- K925531SOLARSHIELD CLIPS1Cleared 510(K)
- K935446VISUAL HEALTHSHIELDS1Cleared 510(K)
- K935678SUNGLASS FRAME1Cleared 510(K)
- K930659SUNGLASSES1Cleared 510(K)
- K934277SUNGLASSES1Cleared 510(K)
- K935231TALE SPIN SUNSHADES1Cleared 510(K)
- K934402COOL KIDS MIRROR SHADES1Cleared 510(K)
- K934197OPTIKOS SHAMI, INC. SUNGLASSES1Cleared 510(K)
- K933223SUNGLASSES1Cleared 510(K)
- K933189SPECTACLE FRAMES AND SUNGLASSES1Cleared 510(K)
- K935541SUNGLASSES1Cleared 510(K)
- K935165BIKER MICE SUNGLASSES1Cleared 510(K)
- K934020SUNGLASSES1Cleared 510(K)
- K933938FINE OPTICS SUNGLASSES1Cleared 510(K)
- K932469VISUAL SCENE SUNGLASSES1Cleared 510(K)
- K932151FLOATS SUNGLASSES1Cleared 510(K)
- K933323RUSSELL & HANCOCK 524 AND 422 SUNGLASSES1Cleared 510(K)
- K934852COOL KIDS HIP SHADES1Cleared 510(K)
- K934837SUNGLASSES1Cleared 510(K)
- K934403SUNGLASSES1Cleared 510(K)
- K934374SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K925539SUNGLASSES1Cleared 510(K)
- K934400REVO CLASSIC/SHAPES SUNGLASSES1Cleared 510(K)
- K930585SUNGLASSES1Cleared 510(K)
- K934307BUTTERFLY NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K934309DISCO SUNGLASSES NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K934308CHILD NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K934304ANIMAL NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K934305AVIATOR NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K932416PROMOTIONAL SUNGALSSES1Cleared 510(K)
- K931990SUNGLASSES1Cleared 510(K)
- K931451GLASSES1Cleared 510(K)
- K930858MODISSA 90 S.R.L. SUNGLASSES1Cleared 510(K)
- K934120NON-PRESCRIPTION EYEGLASS FRAMES & SUNGLASSES VARIOUS STYLES1Cleared 510(K)
- K934081SPECTACLE SUN GLASSES (NON PRESCRIPTION)1Cleared 510(K)
- K934034SPECTACLE SUNGLASSES (NON-PERSCRIPTION)1Cleared 510(K)
- K933905ASICS SUNGLASSES1Cleared 510(K)
- K933718MUGNIER JERIK SUNGLASSES1Cleared 510(K)
- K933089FASHION ITALIANA EYEWEAR1Cleared 510(K)
- K932838SUNGLASSES AND OPTICAL FRAMES, CARBON AND METAL FRAMES1Cleared 510(K)
- K931389ITEM # 754 HOT FLIP SHADES1Cleared 510(K)
- K933138INFLUENCE,ARIA,MASERATI,ROCHAS,ANGELO,TARLAZZI1Cleared 510(K)
- K932275SUNGLASSES1Cleared 510(K)
- K931910BRILLENERZEUGUNG POMBERGER OR MULTIPLE SUNGLASSES1Cleared 510(K)
- K931431FLOATER SUNGLASSES1Cleared 510(K)
- K931408SUNGLASSES1Cleared 510(K)
- K931055ITEM # 755 HOT SUNGLASSES1Cleared 510(K)
- K925570SUNGLASSES1Cleared 510(K)
- K925187ALIBI OPTICAL FRAMES AND SUNGLASSES1Cleared 510(K)
- K933734MARCHON/MARCOLIN SUNGLASSES1Cleared 510(K)
- K933616MULTIPLE1Cleared 510(K)
- K933254EYEGLASS FRAMES1Cleared 510(K)
- K932939SUNGLASSES1Cleared 510(K)
- K932940SUNGLASSES1Cleared 510(K)
- K932941SUNGLASSES1Cleared 510(K)
- K932814NON-PRESCRIPTION SUGLASSES1Cleared 510(K)
- K932646ROLLENS POST-MYDRIATIC SUNGLASS1Cleared 510(K)
- K931718SPIRIT SHIELD1Cleared 510(K)
- K931504SUNGLASSES1Cleared 510(K)
- K926096NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K925428SUNGLASSES1Cleared 510(K)
- K925224U108, U105, G209-B1Cleared 510(K)
- K930198LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)1Cleared 510(K)
- K930562SOLSTAR BRILLENMODE SUNGLASSES1Cleared 510(K)
- K932018OUT FOR FUN! HAPPY MEAL MCDONALDLAND SUNGLASSES1Cleared 510(K)
- K931525SUNGLASSES1Cleared 510(K)
- K932135OTT SUNGLASSES1Cleared 510(K)
- K926065EYEGLASS FRAMES AND SUNGLASSES1Cleared 510(K)
- K925803A.J. MORGAN SUNGLASSES1Cleared 510(K)
- K922886VARIOUS MODELS OF SUNGLASSES1Cleared 510(K)
- K925736NON-PRES SUNGLASSES/SPEC FRAMES (PLASTIC & METAL)1Cleared 510(K)
- K923746MMELALENS SUNGLASSES1Cleared 510(K)
- K922120SERIOUS SKINGLASSES1Cleared 510(K)
- K923375PLAYSKOOL SUNGLASSES1Cleared 510(K)
- K923374VARIOUS SUNGLASSES1Cleared 510(K)
- K923778SUNGLASSES1Cleared 510(K)
- K924938THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES1Cleared 510(K)
- K924548XENO MELANIN LENS1Cleared 510(K)
- K922370NEW EDITIONS CHILDRENS SUNGLASSES1Cleared 510(K)
- K924032CORNEAL ANALYSIS SYSTEMS(TM)1Cleared 510(K)
- K914618SUNGLASSES1Cleared 510(K)
- K922464SUNGLASSES1Cleared 510(K)
- K920672SUNGLASSES, NON PRESCRIPTION1Cleared 510(K)
- K921685SOLAZ1Cleared 510(K)
- K915266VISOR SUNGLASSES/LENS/NOVELTY VISOR1Cleared 510(K)
- K922508RUBBER FRAME SUNGLASSES1Cleared 510(K)
- K914473SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES1Cleared 510(K)
- K920836SUNGLASSES1Cleared 510(K)
- K922121SUNGLASSES1Cleared 510(K)
- K921444DIGI SPORTLENS SYSTEM1Cleared 510(K)
- K920701INDUSTRIAL STRENGTH EYEWEAR1Cleared 510(K)
- K920807SUNGLASSES1Cleared 510(K)
- K920764SUNGLASSES AND EYEGLASS FRAMES1Cleared 510(K)
- K920211SUN/SPORTGLASSES1Cleared 510(K)
- K920169SUNGLASSES1Cleared 510(K)
- K920344SUNGLASSES1Cleared 510(K)
- K915263SUNGLASSES/READING GLASSES1Cleared 510(K)
- K915661TECHNA SUN LENS1Cleared 510(K)
- K915605SUNGLASSES/READING GLASSES1Cleared 510(K)
- K914310OPTICAL FRAMES & SUNGLASSES1Cleared 510(K)
- K913419REGENCY, COMPARE, SUN OPTICS SUNGLASSES1Cleared 510(K)
- K920165SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K913686SUNSHADES, ACRYLIC LENSES, SILVER COATED #HX-6021Cleared 510(K)
- K914766SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES1Cleared 510(K)
- K912509MOSSIMO OPTIC EYEWEAR1Cleared 510(K)
- K914425PYRAMID SUNGLASSES/READING GLASSES1Cleared 510(K)
- K914407PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K913640DR. DEAN EDELL SOLARBLOC SUNGLASSES1Cleared 510(K)
- K913745DUCAL SIDE SHIELD SUNGLASS1Cleared 510(K)
- K913388THE PAN.OPTX SPORTGLASS1Cleared 510(K)
- K912863DESERT SHIELD SUNGLASSES1Cleared 510(K)
- K912608STAR*SHADES(TM) SUNGLASSES1Cleared 510(K)
- K911277ORIGINALS1Cleared 510(K)
- K911766SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.1Cleared 510(K)
- K910415SUNGLASSES1Cleared 510(K)
- K910597SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #21Cleared 510(K)
- K910904INTEGO1Cleared 510(K)
- K910126SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA)1Cleared 510(K)
- K910127SUNGLASSES, NON-PRESCRIPTION (POLINELLI)1Cleared 510(K)
- K910125SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA)1Cleared 510(K)
- K905864SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K902343SUNGLASSES1Cleared 510(K)
- K910141CHILDREN SUNGLASSES1Cleared 510(K)
- K903065PRIMARY MANUFACTURER SUNGLASSES1Cleared 510(K)
- K905041SUNGLASSES1Cleared 510(K)
- K904981FUNKY SUNGLASS1Cleared 510(K)
- K904161JMB TRADING COMPANY SUNGLASSES1Cleared 510(K)
- K902225CHILDRENS SUNGLASSES1Cleared 510(K)
- K904281NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K904197CHILDRENS SUNGLASSES1Cleared 510(K)
- K903487SOLARSHIELDS ENCORE1Cleared 510(K)
- K904585POST MYDRIATIC SPECTACLES1Cleared 510(K)
- K903902SUNGLASSES1Cleared 510(K)
- K902301SUNSHADES, ACRYLIC LENSES #SG-011Cleared 510(K)
- K903721WRAP-AROUND INSTANT SUNGLASSES1Cleared 510(K)
- K903720FLAT FIT-IN SUNGLASSES1Cleared 510(K)
- K903719FLAT SLIP-IN SUNGLASSES1Cleared 510(K)
- K902224SUNGLASSES1Cleared 510(K)
- K903826SARAH COVENTRY SUNGLASSES1Cleared 510(K)
- K902519EYE SPY SUNGLASSES1Cleared 510(K)
- K900907CARTIER SUNGLASSES, MUST DE1Cleared 510(K)
- K903739SUNGLASSES W/NON PRESCRIPT LENSES W/PHOTO SENSITIV1Cleared 510(K)
- K902280RAD-X GLASSES1Cleared 510(K)
- K903202TOY SUNGLASSES1Cleared 510(K)
- K897090SUNGLASSES1Cleared 510(K)
- K902868RUBBER SUNGLASSES1Cleared 510(K)
- K902415VISION JANTZEN SUNGLASSES1Cleared 510(K)
- K902033MAGIC HOT SHADES 70116, 70118, 701191Cleared 510(K)
- K900877OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION1Cleared 510(K)
- K902186SUNGLASSES1Cleared 510(K)
- K902117FESAN SUNGLASSES1Cleared 510(K)
- K901802TOY SUNGLASSES1Cleared 510(K)
- K902414OPTI-RAY SUNGLASSES1Cleared 510(K)
- K902385SUNSHADES, ACRYLIC LENSES, ORDER #SG-011Cleared 510(K)
- K902322SOLAR-MATES SUNGLASSES, BONJOUR EYEWEAR1Cleared 510(K)
- K901945SUNGLASSES - IMPACT RESISTANT LENSES (ACRYLIC)1Cleared 510(K)
- K900944SUNGLASSES1Cleared 510(K)
- K900936NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K901571SUNGLASSES STYLE #(CM-1989)1Cleared 510(K)
- K901570SUNGLASSES STYLE #(1137)1Cleared 510(K)
- K900764SUNGLASS, NON-PRESCRIPTION1Cleared 510(K)
- K901572SUNGLASSES STYLE #(70116)1Cleared 510(K)
- K901160NUBALOO(R) SUNGLASSES1Cleared 510(K)
- K901167(EYEGLASS) FRAMES AND SUNGLASSES1Cleared 510(K)
- K901036NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K901299CELEBRITY-CARENZA-SUNGEAR-SUMMIT SUNGLASSES1Cleared 510(K)
- K901168NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K901047SUNGLASSES1Cleared 510(K)
- K901468CHILDREN'S SUNGLASSES1Cleared 510(K)
- K900522MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS1Cleared 510(K)
- K900521MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER1Cleared 510(K)
- K900520MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS1Cleared 510(K)
- K900529MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES1Cleared 510(K)
- K900526MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS1Cleared 510(K)
- K900527MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES1Cleared 510(K)
- K900528MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES1Cleared 510(K)
- K900524MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER1Cleared 510(K)
- K901161SOLAR SHADES(TM) SUNGLASSES1Cleared 510(K)
- K901100VECTRA(TM)1Cleared 510(K)
- K900090NIKON MULTI-SPORT SUNGLASSES1Cleared 510(K)
- K900387DISCO SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K900525MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE1Cleared 510(K)
- K900523MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.1Cleared 510(K)
- K900381COLORVISION SUNGLASSES1Cleared 510(K)
- K900382BLUBLOCKER SUNGLASSES1Cleared 510(K)
- K900383BULLET SUNGLASSES1Cleared 510(K)
- K900046NOVELTY GRADUATION SUNGLASSES; NON-PRESCRIPTION1Cleared 510(K)
- K896768NON-PRESCRIPTION SUNGLASSES1Cleared 510(K)
- K896716PLASTIC SUNGLASSES1Cleared 510(K)
- K893986NEW WEST SUNGLASSES1Cleared 510(K)
- K891597NOSEY SHADES (SUNGLASSES) NONPRESCRIPTION1Cleared 510(K)
- K890725PHOTOCHROMIC LENS1Cleared 510(K)
- K890081CALIUS-ISABEL CANOVAS SUNGLASSES1Cleared 510(K)
- K884878SOLARETTES1Cleared 510(K)
- K885275ASSENAT-BLESCHET SUNGLASSES1Cleared 510(K)
- K883771SUNGLASSES, IMPORTED1Cleared 510(K)
- K882769SUNGLASSES, NON-PRESCRIPTION1Cleared 510(K)
- K872786SUNGLASSES1Cleared 510(K)
- K882813NEOLENS SUNGLASSES1Cleared 510(K)
- K881594SUNGLASSES1Cleared 510(K)
- K881419PLASTIC FRAME & LENS SUNGLASS1Cleared 510(K)
- K881278SPECTACLE, FRAME AND SUNGLASSES1Cleared 510(K)
- K880709CALIFORNIA CONVERTIBLES (SUNGLASSES)1Cleared 510(K)
- K873966SUNGLASSES (NONPRESCRIPTION)1Cleared 510(K)
- K874722HOLLYWOODS COOL SHADES1Cleared 510(K)
- K875067GOOD LOOKS DAZZLERS1Cleared 510(K)
- K873405SUPERVISOR SUN GOGGLES(TM)1Cleared 510(K)
- K873983CAPTAIN POWER SUNGLASSES STYLES: #1020 #10211Cleared 510(K)
- K873685NONPRESCRIPTION SUNGLASSES1Cleared 510(K)
- K872503FH LEN1Cleared 510(K)
- K872218COOL SHADES1Cleared 510(K)
- K871800SUMMIT OPTICS POST-MYDRIATIC SPECTACLES1Cleared 510(K)
- K870997SOLA UV GARD(TM) SUNGLASSES1Cleared 510(K)
- K870219LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS1Cleared 510(K)
- K870178SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS1Cleared 510(K)
- K864543SUNGLASSES1Cleared 510(K)
- K863886SPORTLIFE SUNWEAR1Cleared 510(K)
- K864399FISHER PRICE SUNJAMMERS1Cleared 510(K)
- K860953SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K863651POLAREX AND POLAREX MLD1Cleared 510(K)
- K862719SOLARSHIELDS1Cleared 510(K)
- K861927CHILDREN'S SUNGLASSES1Cleared 510(K)
- K860043WINK-EASE DISPOSABLE PROTECTIVE1Cleared 510(K)
- K854879SUNGLASSES1Cleared 510(K)
- K854818SUNGLASSES1Cleared 510(K)
- K853043700-123 EYE SHADE1Cleared 510(K)
- K854264SUNGLASSES/OPTICAL FRAMES1Cleared 510(K)
- K853921ALL KINDS OF SUNGLASSES1Cleared 510(K)
- K853790BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER1Cleared 510(K)
- K852902METALLIC SUNGLASSES1Cleared 510(K)
- K852830SUNNY SUN MAGNIFYING GLASSES1Cleared 510(K)
- K852773SUNGLASSES1Cleared 510(K)
- K851698ANNE MARIE PERRIS SUNGLASSES AND FRAMES1Cleared 510(K)
- K851062DERAPAGE EYEWEAR BY VITALONI1Cleared 510(K)
- K841794SUNGLASSES1Cleared 510(K)
- K832564DISCO SUNGLASSES/HEADBAND SUNGLASSES1Cleared 510(K)
- K820016UVEX ALPHA, BETA, GAMMA & DELTA SUN1Cleared 510(K)
- K803308FASHION SUNGLASSES1Cleared 510(K)
- K802082POLARIS SPECTACLE FRAMES & LENSES1Cleared 510(K)
- K801922TUTTIFRUTTI (NON-PRES. SUNGLASSES)1Cleared 510(K)
- K801196LIBCO SUNGLASSES1Cleared 510(K)
- K791499RAY-BAN SUN GLASSES1Cleared 510(K)
- HQZFrame, Spectacle1Product Code
- 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
SUNGLASSES
- Page Type
- Cleared 510(K)
- 510(k) Number
- K941084
- 510(k) Type
- Traditional
- Applicant
- BLUE GEM SUNGLASSES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/14/1995
- Days to Decision
- 524 days
- Submission Type
- Statement