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
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- K250425Ultraviolet Phototherapy Device2Cleared 510(K)
- K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)2Cleared 510(K)
- K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)2Cleared 510(K)
- K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)2Cleared 510(K)
- K233811DT Controlled Phototherapy Equipment2Cleared 510(K)
- K223882Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)2Cleared 510(K)
- K2303823 Series NeoLux2Cleared 510(K)
- K230076Enhanced AURORA™ Medical Diode System, and related accessories2Cleared 510(K)
- K2208401 Series Phototherapy Equipment2Cleared 510(K)
- K210004i8 Tanning Booth2Cleared 510(K)
- K2125107 Series Phototherapy Device2Cleared 510(K)
- K210881M Series Phototherapy Equipment2Cleared 510(K)
- K202827308nm Excimer UV-light Skin Therapy System2Cleared 510(K)
- K200971308nm Excimer System2Cleared 510(K)
- K192411Psoria-Shield AURORA2Cleared 510(K)
- K192642308nm Excimer System2Cleared 510(K)
- K191571UV Radiation Treatment System2Cleared 510(K)
- K191086Exciplex2Cleared 510(K)
- K181805UV Phototherapy2Cleared 510(K)
- K182215ClearLink Controlled Phototherapy Equipment2Cleared 510(K)
- K172273308nm Excimer System2Cleared 510(K)
- K173436Luma Light System2Cleared 510(K)
- K171702Exciplex308nm2Cleared 510(K)
- K170489Skylit Phototherapy System2Cleared 510(K)
- K1537493 Series Phototherapy Unit2Cleared 510(K)
- K151795ML24000 UVA-1 Phototherapy Cabinet2Cleared 510(K)
- K150752GME ExSys 3082Cleared 510(K)
- K150912Houva-NET Control System2Cleared 510(K)
- K134009UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL2Cleared 510(K)
- K132643UV PHOTOTHERAPY2Cleared 510(K)
- K130519PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS2Cleared 510(K)
- K111049MOBILE VERSA LIGHT2Cleared 510(K)
- K110912SMART TOUCH UVTHERAPY MULTIPLE MACHINE2Cleared 510(K)
- K1111724 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES2Cleared 510(K)
- K103204SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY2Cleared 510(K)
- K103708ML24000 UVA-1 PHOTOTHERAPY UNIT2Cleared 510(K)
- K103540PSORIA-LIGHT2Cleared 510(K)
- K1003781 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X42Cleared 510(K)
- K091568LH-75 PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K090097LH-75T PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K082731ML24000 UVA-1 PHOTOTHERAPY CABINET2Cleared 510(K)
- K073503VERSA LITE2Cleared 510(K)
- K073587DERMAPAL WITH DIGITAL TIMER2Cleared 510(K)
- K073066308 DERMATOLOGICAL EXCIMER SYSTEM2Cleared 510(K)
- K072035RESOLVE UVB PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K070934PANOSOL II TRU-BLU, MODEL UBL-4172Cleared 510(K)
- K0636213 SERIES PHOTOTHERAPY CABINET2Cleared 510(K)
- K061589SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY2Cleared 510(K)
- K061295VERSACLEAR SKIN THERAPY SYSTEM, MODEL 1002Cleared 510(K)
- K051330UVBIOTEK MODELS 3200B AND 4000B2Cleared 510(K)
- K052660MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO2Cleared 510(K)
- K050080CYNOSUREA ECLILITE AND ECLILITE U2Cleared 510(K)
- K050695FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT2Cleared 510(K)
- K0425023 SERIES PHOTOTHERAPY CABINET2Cleared 510(K)
- K041212HOUVA 3 PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K033946LOVELY SYSTEM2Cleared 510(K)
- K040062LEVIA PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K031800SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:2Cleared 510(K)
- K024020THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K022104DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ2Cleared 510(K)
- K021762BCLEAR2Cleared 510(K)
- K022165THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-22Cleared 510(K)
- K021514PHILIPS PLS9W/12/2P UVB2Cleared 510(K)
- K021092PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B2Cleared 510(K)
- K020591BCLEAR2Cleared 510(K)
- K011197DERMACLEAR UV-B PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K982082HANDISOL WOUND HEALING2Cleared 510(K)
- K935525PHOTOTHERAPEUTIX MODEL 2480AB2Cleared 510(K)
- K933952PHOTOTHERAPEUTIX MODEL 800B2Cleared 510(K)
- K933954PHOTOTHERAPEUTIX MODEL 2400B2Cleared 510(K)
- K933953PHOTOTHERAPEUTIX MODEL 1650B2Cleared 510(K)
- K935524PHOTOTHERAPEUTIX MODEL 3200A2Cleared 510(K)
- K935526PHOTOTHERAPEUTIX MODEL 1600B2Cleared 510(K)
- K935572SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT2Cleared 510(K)
- K935840TL 20W/12/RS & TL 40W/12/RS2Cleared 510(K)
- K934808UVISOL AND UVISOL II2Cleared 510(K)
- K933146ESB 2400 SEI2Cleared 510(K)
- K930856PSORALITE2Cleared 510(K)
- K924969PHOTOTHERAPY TIMER2Cleared 510(K)
- K925171FREE SUN PRO DESIGN 3000 AND 38002Cleared 510(K)
- K924077HANDISOL2Cleared 510(K)
- K922963TL100W/122Cleared 510(K)
- K915426MEDICAL SUNLAMP FOR PHOTOTHERAPY2Cleared 510(K)
- K913760PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT2Cleared 510(K)
- K910767TL100W/01 UVB LAMP2Cleared 510(K)
- K904427PANOSOL II UVB-2062Cleared 510(K)
- K904428PANOSOL II UAB-2282Cleared 510(K)
- K904426PANOSOL II UVA-2182Cleared 510(K)
- K904425MODEL 6/01 UV-B FIXTURE2Cleared 510(K)
- K901324U.V. SUNLAMP 95UF-II2Cleared 510(K)
- K900649FLUORESCENT T12 UVA LAMP2Cleared 510(K)
- K900693U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)2Cleared 510(K)
- K896831ALISUN SUNTANNING BED2Cleared 510(K)
- K896191SUNTANNING BED, INC. T12 UVA TANNING LAMPS2Cleared 510(K)
- K895410REMINGTON TANFASTIC HANDHELD TANNING WAND2Cleared 510(K)
- K885026HOUVA II UVB2Cleared 510(K)
- K885029HOUVA II UVA/UVB2Cleared 510(K)
- K890084PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 450002Cleared 510(K)
- K885184SHAW SUN SYSTEMS MODEL 24002Cleared 510(K)
- K885025HOUVA II UVA2Cleared 510(K)
- K883929TANNING BED2Cleared 510(K)
- K883952U. V. SUNLAMP 95UF-112Cleared 510(K)
- K882722HOUVA-BED2Cleared 510(K)
- K881923ULTRAVIOLET RESOURCES INT'L MODEL 2-FS722Cleared 510(K)
- K881385PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL2Cleared 510(K)
- K874889U.V. SUNLAMP 95 UF-112Cleared 510(K)
- K873430FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-122Cleared 510(K)
- K872648SOLAR GOLD UVA SUN TANNING BED2Cleared 510(K)
- K872651PANOSOL 2000 624-4142Cleared 510(K)
- K872706PANOSOL 2000 624-6162Cleared 510(K)
- K872707PANOSOL 2000 624-4042Cleared 510(K)
- K872650PANOSOL 2000 624-6042Cleared 510(K)
- K872649HAND/FOOT UVA/UVB 624-2242Cleared 510(K)
- K872605HAND/FOOT UVA 624-2182Cleared 510(K)
- K872604HAND/FOOT 624-2082Cleared 510(K)
- K871237SUN CAPSULE I & II SUNTANNING BOOTH2Cleared 510(K)
- K870167U.V. SUNLAMP 95UF-112Cleared 510(K)
- K864511PSORALITE 18400 SERIES2Cleared 510(K)
- K864510PSORALITE 12800 SERIES2Cleared 510(K)
- K864546MAXI-TAN DEVICE2Cleared 510(K)
- K864907SUNTANNING LAMP2Cleared 510(K)
- K864485SUNFIT SUNLAMP2Cleared 510(K)
- K863937OSRAM ULTRAMED 400 W2Cleared 510(K)
- K863555BREMI BEAUTY BRONZE2Cleared 510(K)
- K863518WEINGART MODEL 1000 SUNLAMP PRODUCT2Cleared 510(K)
- K862608SPERTILITE PHOTOTHERAPY LAMP2Cleared 510(K)
- K862372ULTRATAN TANNING SYSTEM2Cleared 510(K)
- K862341TANNING SOFA2Cleared 510(K)
- K861963ULTRALITE HF1236 HAND AND FOOT SYSTEM2Cleared 510(K)
- K862263PERSUNAL TAN, MODEL NO. HU-0208L2Cleared 510(K)
- K862142SUN-DREAMER SUNTANNING BED2Cleared 510(K)
- K862097FACE TANNER2Cleared 510(K)
- K861989MODIFICATION OF SUNTANA SUN SYSTEM BED2Cleared 510(K)
- K861705CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP)2Cleared 510(K)
- K861636MIAMI-SUNNY2Cleared 510(K)
- K861570ALPHA TAN 1000 AND ALPHA TAN 12002Cleared 510(K)
- K861447ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/9002Cleared 510(K)
- K861533SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS2Cleared 510(K)
- K861107TAN MATE HOME TANNING UNIT2Cleared 510(K)
- K861076RESIDENTIAL TANNING UNIT2Cleared 510(K)
- K860929ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT2Cleared 510(K)
- K860932ULTRASUN 1000 & 2000 SUNTANNING UNIT2Cleared 510(K)
- K860930ULTRASUN 2500 SUNTANNING UNIT2Cleared 510(K)
- K860931ULTRASUN 3000 AND 5000 SUNTANNING UNIT2Cleared 510(K)
- K860859UVA SUN SYSTEMS2Cleared 510(K)
- K860856SILGMANN SOLARIUM SUN-MOBIL MODEL 09182Cleared 510(K)
- K860370SAFE SUN 700 HOME TANNING UNIT2Cleared 510(K)
- K860567NORDIC SUN HOME TANNING UNIT2Cleared 510(K)
- K860566NORDIC SUN 24 LAMP TANNING BED2Cleared 510(K)
- K860509SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE2Cleared 510(K)
- K860489EUROTAN BY AYK2Cleared 510(K)
- K860198MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING2Cleared 510(K)
- K854750TOP SUN2Cleared 510(K)
- K860347SUNLAMP MODELS 24N, 30R, 30RE, 37RE2Cleared 510(K)
- K860144SUM TAN VI2Cleared 510(K)
- K855162ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR2Cleared 510(K)
- K860117KRYPTOSOL (SUN LAMP)2Cleared 510(K)
- K854932ECUMOL ULTRAVIOLET FACE TANNING UNITS2Cleared 510(K)
- K854707SUNTAINNING BOOTH2Cleared 510(K)
- K854594PHOENIX U.V.A. SUNTAN BEDS2Cleared 510(K)
- K854498SPECTRA 7242Cleared 510(K)
- K854515SHAW SUN SYSTEMS 1000, 2000 & 32002Cleared 510(K)
- K854020G-T 10002Cleared 510(K)
- K854224GOLDEN RULE SUN TANNING BEDS2Cleared 510(K)
- K854170I.S.M. PRODUCT FAMILY MODEL R3600C2Cleared 510(K)
- K854154FOX BED MODEL 20012Cleared 510(K)
- K854131PHASE V-MODEL 1500 RUVA2Cleared 510(K)
- K854111EXPRESS TAN SUN CANOPY2Cleared 510(K)
- K852534ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-92Cleared 510(K)
- K854171I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC2Cleared 510(K)
- K854004FLUORESCENT T12 UVA TANNING LAMP2Cleared 510(K)
- K853846SUN TANNING BED2Cleared 510(K)
- K853833TOP SUN MODELS 100,101,103 &139, 139-1, 139-32Cleared 510(K)
- K853911UV-A SUNTANNING EQUIPMENT2Cleared 510(K)
- K853752SUN KING2Cleared 510(K)
- K853692SUN TANNING BED MODEL EC-3RF2Cleared 510(K)
- K853679SUNJET MODELS 240/2802Cleared 510(K)
- K853587UVATAN INDUS. UVATAN 900C, 900B/800 & 600C2Cleared 510(K)
- K853545FLOURESCENT T12 UVA TANNING LAMP2Cleared 510(K)
- K853394600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L2Cleared 510(K)
- K853248CHALLENGER SUNRISE2Cleared 510(K)
- K853177ECUMOL ULTRAVIOLET SUNTANNNING BEDS2Cleared 510(K)
- K853046TAN MODEL I2Cleared 510(K)
- K852957SAHARA SUNBED2Cleared 510(K)
- K852684WALDMANN F85/100W UV212Cleared 510(K)
- K852576WALDMANN F85/100W UV62Cleared 510(K)
- K851408SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER2Cleared 510(K)
- K852579THE SUNTANNING CO. TANNING BED2Cleared 510(K)
- K852348PHILIPS SOLARIUM HP 31342Cleared 510(K)
- K852243KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS2Cleared 510(K)
- K852290PRIVATAN HOME TANNING CENTER2Cleared 510(K)
- K852149PORTASUN MODEL 600/LI SUNLAMP2Cleared 510(K)
- K852053ORIGINAL ULTRAVIOLET SUNTANNING LAMP2Cleared 510(K)
- K851858FOLD AWAY HUT2Cleared 510(K)
- K851859FACIAL/UPPER BODY UNIT2Cleared 510(K)
- K845029SURGICAL POWER MAGNET2Cleared 510(K)
- K851532SUNTANNING EQUIPMENT2Cleared 510(K)
- K851535PHILIPS UV-A SOLARIUM TYPE HP 31402Cleared 510(K)
- K851534PHILIPS UV-A SOLARIUM TYPE HP 31502Cleared 510(K)
- K851533PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP2Cleared 510(K)
- K851536PHILIPS UV-A SOLARIUM TYPE HP 31412Cleared 510(K)
- K851255SUN BEDS2Cleared 510(K)
- K850660SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY2Cleared 510(K)
- K850493SUNSHOWER MODEL HU-01-12L2Cleared 510(K)
- K850203PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP2Cleared 510(K)
- K850204PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP2Cleared 510(K)
- K850205PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP2Cleared 510(K)
- K850206PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP2Cleared 510(K)
- K845001MARTANIQUE 6-TUBE HOME SOLARIUM2Cleared 510(K)
- K850042SOLAR TAN - SOLARIA IV2Cleared 510(K)
- K845028MARTANIQUE 7-TUBE RUVA HOME SOLARIUM2Cleared 510(K)
- K844870SUNTAN CONNECTIONS BAHAMA SUN-BOOTH2Cleared 510(K)
- K843902SOLAR-GOLD UV-A BY EOS2Cleared 510(K)
- K844039AZTECH INDUSTRIES SUNTANNING BED AZ1002Cleared 510(K)
- K843306UVA SUNTANNING UNITS VARIOUS MODELS2Cleared 510(K)
- K843814EMUMOL ULTRAVIOLET SUNTANNING LAMP2Cleared 510(K)
- K843647MTI 1200, 401 & 35002Cleared 510(K)
- K842975BROWNIE BOOTH BB12Cleared 510(K)
- K842787SUNBED2Cleared 510(K)
- K842575ULTRA-VIOLET A SOURCE LIGHT EMITTING2Cleared 510(K)
- K842384ULTRA-VIOLET EMITTING SUNLAMP PRODUCT2Cleared 510(K)
- K841614SUN BEDS2Cleared 510(K)
- K840931SUN BEDS2Cleared 510(K)
- K840158KOSMEDICO GMBH SUNLAMP PRODUCTS2Cleared 510(K)
- K840132TANSEEKER2Cleared 510(K)
- K840133ULTRAVIOLET TANNING SYSTEMS2Cleared 510(K)
- K840137SILGMANN SOLARIUM S-TYPE 1218 COMBO2Cleared 510(K)
- K834488MERRITTAN SUN SYSTEM2Cleared 510(K)
- K833524SUNBED/SUNROOF TANNING DEVICE2Cleared 510(K)
- K834495UV-A SUNTANNING EQUIPMENT 1000-80002Cleared 510(K)
- K834493EVERTAN SUNTAN BEDS2Cleared 510(K)
- K834492SALON -BODY TANNING BED2Cleared 510(K)
- K834491UVA SUNTANNING LAMPS2Cleared 510(K)
- K833511UV-A SUNTANNING EQUIPMENT-SILGMANN2Cleared 510(K)
- K833490SILGMANN SOLARIUMS-TYPE 1218 CANOPY &2Cleared 510(K)
- K833350KOSMEDICO GMBH SUN LAMP2Cleared 510(K)
- K833527UV-A SUN TANNING EQUIPMENT2Cleared 510(K)
- K833240INT'L TANNING SYSTEMS B.V2Cleared 510(K)
- K832794SUNTANNING BOOTHS AND BEDS2Cleared 510(K)
- K827890FOLDALITE UNIT2Cleared 510(K)
- K820492SPECTRA3052Cleared 510(K)
- K812225METEC HELARIUM LOUNGE & SKY UNITS2Cleared 510(K)
- K820123SUNFLOWER2Cleared 510(K)
- K813307UVA HEX UNIT2Cleared 510(K)
- K812663SOLARIUM COMBINATION2Cleared 510(K)
- K812446SUNLAMP2Cleared 510(K)
- K812579SUNTANNING HOME UNIT2Cleared 510(K)
- K812543TANARAMA2Cleared 510(K)
- K812521SUNTANNING DEVICE (SEPAR. FROM K812225)2Cleared 510(K)
- K811870UVA SUN TANNING EQUIPMENT2Cleared 510(K)
- K811585F72T12/BL-S/HO UVA SUNLAMP2Cleared 510(K)
- K811586F72T12/BL-S/SHO-O UVA SUNLAMP2Cleared 510(K)
- K810796SUNTAN BOOTH2Cleared 510(K)
- K811029SUNLAMP2Cleared 510(K)
- K803264SUNLAMP2Cleared 510(K)
- K810688THE SUNFACTORY2Cleared 510(K)
- K810476B.J.'S UVA SUN TAN BED W/SUN ROOF2Cleared 510(K)
- K801017TANIT COMMERCIAL SUNTAN BOOTH2Cleared 510(K)
- K800950TANIT HOME SUNTANNING UNIT2Cleared 510(K)
- K800160SUN-TANNING BOOTHS2Cleared 510(K)
- K792500UVB LIGHT BOX - UVB LIGHT BOOTH2Cleared 510(K)
- K790167SUNLAMP2Cleared 510(K)
- K770862BLACK LAMPS,F72T12/BL/HO2Cleared 510(K)
- K761179PSORALITE2Cleared 510(K)
- K761189HOUVA-LITE SOLE UNIT #5022Cleared 510(K)
- K761188HOUVA-LITE PALM UNIT #5012Cleared 510(K)
- K761186HOUVA-LITE ARM UNIT #6012Cleared 510(K)
- K761187HOUVA-LITE LEG UNIT #7012Cleared 510(K)
- K760471LAMP, FLOURESCENT BLACK, HIGH OUTPUT2Cleared 510(K)
- K760482SUNLAMP (F40-UVB & F20-UVB)2Cleared 510(K)
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- GEJCarrier, Ligature1Product Code
- GENForceps, General & Plastic Surgery1Product Code
- GEOFile, Surgical, General & Plastic Surgery1Product Code
- GESBlade, Scalpel1Product Code
- GETMotor, Surgical Instrument, Pneumatic Powered1Product Code
- GEXPowered Laser Surgical Instrument2Product Code
- GEYMotor, Surgical Instrument, Ac-Powered1Product Code
- GFABlade, Saw, General & Plastic Surgery, Surgical1Product Code
- GFBHead, Surgical, Hammer1Product Code
- GFCDriver, Surgical, Pin1Product Code
- GFDDermatome1Product Code
- GFEBrush, Dermabrasion, Powered1Product Code
- GFFBur, Surgical, General & Plastic Surgery1Product Code
- GFGBit, Surgical1Product Code
- GFIOsteotome, Manual1Product Code
- GFJMallet, Surgical, General & Plastic Surgery1Product Code
- HABSaw, Powered, And Accessories1Product Code
- HAMApparatus, Electrosurgical2Product Code
- HBIIlluminator, Fiberoptic, Surgical Field2Product Code
- HBTApplier, Hemostatic Clip1Product Code
- HCFInstrument, Ligature Passing And Knot Tying1Product Code
- HJELamp, Fluorescein, Ac-Powered2Product Code
- HMPPad, Eye1Product Code
- HRBMicroscope, Operating, Non-Electric, Ophthalmic1Product Code
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic1Product Code
- HRQHemostat1Product Code
- HSOSaw1Product Code
- HTCPliers, Surgical1Product Code
- HTDForceps1Product Code
- HTEElevator1Product Code
- HTFCurette1Product Code
- HTRRasp1Product Code
- HTZInstrument, Cutting, Orthopedic1Product Code
- HWMOsteotome1Product Code
- HXDClamp1Product Code
- HXLMallet1Product Code
- HXRSpatula, Orthopedic1Product Code
- HXTTape, Orthopedic1Product Code
- HYAForceps, Wire Holding1Product Code
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered2Product Code
- JCYCatheter, Infusion1Product Code
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered1Product Code
- JEBTable, Surgical With Orthopedic Accessories, Manual1Product Code
- JOSElectrode, Electrosurgical2Product Code
- JOTElectrode, Gel, Electrosurgical2Product Code
- JYCCannula, Ear1Product Code
- JYDChisel, Mastoid1Product Code
- KAMCannula, Sinus1Product Code
- KANChisel, Nasal1Product Code
- KCECannulae, Bronchial1Product Code
- KDCInstrument, Surgical, Disposable1Product Code
- KDDKit, Surgical Instrument, Disposable1Product Code
- KDGChisel (Osteotome)1Product Code
- KFKSaw, Pneumatically Powered1Product Code
- KGLCabinet, Phototherapy (Puva)2Product Code
- KGSRetention Device, Suture1Product Code
- KGWRing (Wound Protector), Drape Retention, Internal2Product Code
- KGYBag, Intestine1Product Code
- KGZAccessories, Catheter1Product Code
- KIKHook, Bone1Product Code
- KOXSolvent, Adhesive Tape1Product Code
- KOYDegreaser, Skin, Surgical1Product Code
- KOZBeads, Hydrophilic, For Wound Exudate Absorption1Product Code
- KQMCamera, Surgical And Accessories1Product Code
- LEJBooth, Sun Tan2Product Code
- LMFAgent, Absorbable Hemostatic, Collagen Based3Product Code
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based3Product Code
- LROGeneral Surgery Tray2Product Code
- LRPTray, Surgical1Product Code
- LRWScissors, General, Surgical1Product Code
- LRYPunch, Surgical1Product Code
- LRZScrewdriver, Surgical1Product Code
- LSAVise, Bench, Surgical1Product Code
- LWGSurgical Table Cushion1Product Code
- LWKRazor, Surgical1Product Code
- LXKScrapper, Skin Specimen1Product Code
- LXZGuard, Instrument1Product Code
- LYVLabel Or Tag, Sterile1Product Code
- LZMGuard, Skin Graft1Product Code
- MCHClip, Hemostatic2Product Code
- MCZSuture Removal Kit1Product Code
- MDAElastomer, Silicone, For Scar Management1Product Code
- MDMInstrument, Manual, Surgical, General Use1Product Code
- MGOClosure, Wound, Adhesive1Product Code
- MIJNeedle, Tumor Localization1Product Code
- MJGDevice, Percutaneous, Biopsy1Product Code
- MKYSystem, Skin Closure1Product Code
- MOQBattery, Replacement, Rechargeable1Product Code
- MPNTissue Adhesive For The Topical Approximation Of Skin2Product Code
- MULGenerator, Electrosurgical, Coagulation, Cancer2Product Code
- MUUSystem, Suction, Lipoplasty2Product Code
- MVRDevice, Anastomotic, Microvascular2Product Code
- MWYSystem, Microwave, Hair Removal2Product Code
- MXGLamp, Uvc, (For Treating Skin And Wounds)2Product Code
- MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)2Product Code
- NABGauze / Sponge,Nonresorbable For External Use1Product Code
- NACDressing, Wound, Hydrophilic1Product Code
- NADDressing, Wound, Occlusive1Product Code
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic1Product Code
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2Product Code
- NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)2Product Code
- NEHAnchor, Fascial2Product Code
- NEUMarker, Radiographic, Implantable2Product Code
- NEWSuture, Surgical, Absorbable, Polydioxanone2Product Code
- NEYSystem, Ablation, Microwave And Accessories2Product Code
- NJCClip, Vas Deferens2Product Code
- NJUSuture, Nonabsorbable, Nitinol2Product Code
- NJZExtractor, Vein1Product Code
- NLKNeedle, Biopsy, Cardiovascular, Reprocessed1Product Code
- NLLStaple, Implantable, Reprocessed2Product Code
- NMJClip, Implantable, Reprocessed2Product Code
- NMTNeedle, Catheter, Reprocessed1Product Code
- NMUNeedle, Gastro-Urology, Reprocessed1Product Code
- NNABiopsy Device, Percutaneous, Reprocessed1Product Code
- NNCNeedle, Aspiration And Needle, Reprocessed1Product Code
- NRBWound Cleaner, Ultrasound2Product Code
- NRJUltrasound, Skin Permeation2Product Code
- NTBSystem, Ablation, Ultrasound And Accessories2Product Code
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2Product Code
- NUVMassager, Vacuum, Light Induced Heating2Product Code
- NVHSuture, Knot, Mechanical2Product Code
- NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women2Product Code
- NWFDrill, Battery Powered, Subungual Hematoma1Product Code
- NWJSuture, Recombinant Technology2Product Code
- NXFGas, Laser Generating1Product Code
- NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)2Product Code
- OABLow Energy Direct Current Thermal Ablation System2Product Code
- ODRElectrosurgical Patient Return Electrode2Product Code
- OEIDrainage Catheter With Antibiotic2Product Code
- OELLaser, Benign Prostatic Hyperplasia2Product Code
- OHOFirst Aid Kit Without Drug1Product Code
- OHSLight Based Over The Counter Wrinkle Reduction2Product Code
- OHTLight Based Over-The-Counter Hair Removal2Product Code
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2Product Code
- OJJBurn Kit Without Drug1Product Code
- OJRVacuum Powered Body Fluid Collection Kit2Product Code
- OJTAspiration Tray1Product Code
- OJUSkin Prep Tray1Product Code
- OJVSingle Use Instrument Tray1Product Code
- OUHSkin Resurfacing Rf Applicator2Product Code
- OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite2Product Code
- OJWShave Prep Kit2Product Code
- OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-12Product Code
- OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus2Product Code
- OLPOver-The-Counter Powered Light Based Laser For Acne2Product Code
- OMDCutaneous Tissue Adhesive With Mesh2Product Code
- OMPNegative Pressure Wound Therapy Powered Suction Pump2Product Code
- ONEPowered Light Based Non-Laser Surgical Instrument2Product Code
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2Product Code
- ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output2Product Code
- ONQElectrosurgical Coagulation For Aesthetic2Product Code
- OOKDermal Cooling Pack/Vacuum/Massager2Product Code
- ORECryogenic, Skin Tag Removal, Otc2Product Code
- ORKLaser Assisted Lipolysis2Product Code
- OTKWound Drain Catheter System2Product Code
- OUBInstrument For Treatment Of Hyperhidrosis2Product Code
- OVNSuture Kit2Product Code
- OXTPercutaneous Surgical Set With Attachments2Product Code
- OYWLaser, Cellulite Appearance2Product Code
- PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction2Product Code
- PBXMassager, Vacuum, Radio Frequency Induced Heat2Product Code
- PBYTemporary Tissue Marker2Product Code
- PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.2Product Code
- PDWInternal Tissue Marker2Product Code
- PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis2Product Code
- PFPSilicone Hydrogel For Scar Management1Product Code
- PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use2Product Code
- PJKTissue Adhesive For Internal Use3Product Code
- PKDLaceration Tray1Product Code
- PKELaparoscopic Cholecystectomy Kit1Product Code
- PKOTransparent Patch For Use In Treatment Of Tattoos2Product Code
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2Product Code
- PMCScalp Cooling System2Product Code
- PMXAbsorbable Collagen Hemostatic Agent With Thrombin3Product Code
- PNLMagnetic Surgical System2Product Code
- PODTemporary, Internal Use Hemostatic2Product Code
- PQIWound Retraction And Protection System2Product Code
- PSNLight Based Imaging2Product Code
- PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt2Product Code
- PUIDrape, Surgical, Exempt2Product Code
- PXNBasic Set-Up Tray1Product Code
- PXOBone Marrow Biopsy Tray1Product Code
- PXPBreast Biopsy / Localization Tray1Product Code
- QRLMultiple Use Blood Lancet For Single Patient Use Only2Product Code
- PXQBurn Dressing Tray1Product Code
- PXRCement And Bone Removal Kit1Product Code
- PXSCholecystectomy Kit1Product Code
- PXUFluid Drainage Tray1Product Code
- PXVGeneral Purpose Instrument Tray1Product Code
- PXWHerniorraphy Kit1Product Code
- PXXIncision Tray1Product Code
- PXYIrrigation Kit (Wounds)1Product Code
- PXZLaparascopic Sphincterotomy Kit1Product Code
- PYALiver Biopsy Kit1Product Code
- PYBMinor Surgical Procedures Tray1Product Code
- PYCParacentesis Tray1Product Code
- PYDPelviscopy Kit1Product Code
- PYEStaple Removal Kit1Product Code
- PYFSterile Puncture Tray1Product Code
- PYGSuction Catheter Kit1Product Code
- PYHSurgical Retractor Kit1Product Code
- PYIThoracic Catheter Insertion Tray1Product Code
- PYJUlcer Wound Tray1Product Code
- PYKVenous Ulcer Kit1Product Code
- PYLWound Drainage Kit1Product Code
- PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers2Product Code
- PZQGeneral Laparoscopic Power Morcellation Containment System2Product Code
- QAIPowered Microneedle Device2Product Code
- QAUHemostatic Device For Endoscopic Gastrointestinal Use2Product Code
- QCRWound Autofluorescence Imaging Device2Product Code
- QCYLaser Absorbing Particles2Product Code
- QDFParathyroid Autofluorescence Detection Device2Product Code
- QDGParathyroid Autofluorescence Imaging Device2Product Code
- QRMMultiple Use Blood Lancet For Multiple Patient Use3Product Code
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications2Product Code
- QHFEnergy Based Device For Treatment Of Tattoos2Product Code
- QJFAutofluorescence Imaging Adjunct Tool For Wounds2Product Code
- QKLLipoaspirate Washing System For Aesthetic Body Contouring2Product Code
- QNMMountable Electromechanical Surgical System For Transluminal Approaches2Product Code
- QPBSystem, Suction, Lipoplasty For Removal2Product Code
- QPXNegative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical2Product Code
- QPZContact Cooling For Skin Lesion Pain Relief2Product Code
- RABSunlamp Products (Pre-Standard)2Product Code
- REFSuntan Bed2Product Code
- REGSuntan Lamp2Product Code
- REHTabletop Sunlamp System2Product Code
- QUBSuction Lipoplasty System For Removal And Transfer2Product Code
- QVJLow Power Electrosurgical Devices For Skin Lesion Destruction2Product Code
- QZNMulti-Photon Imaging2Product Code
- SFGCamera, Surgical, Measurement1Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GME ExSys 308
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150752
- 510(k) Type
- Traditional
- Applicant
- Gme (German Medical Engineering) GmbH
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/31/2015
- Days to Decision
- 130 days
- Submission Type
- Summary