510(k) Report

Devices descending from K013034

800 later devices reach Modification to: Thermacool Iia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K110375Blueshine's Gold SeriesBlueshine Srl20124—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K090762LEDAQuantel Derma GmbH200946—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+7K082938EzlaseBiolase Technology, Inc.200850—
+7K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+7K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+7K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K254185Potenza PrimeJeisys Medical Incorporated20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+8K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+8K253803MILAN SystemLumenis Be, Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+8K251254Ignite RF SystemInMode, Ltd.20260—
+8K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+8K252367InbellaMulti SystemInbella Medical, Inc.20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+8K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K233766Geneo X ElitePollogen, Ltd.20240—
+8K233642InMode RF SystemInMode, Ltd.20244—
+8K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K230167BACK 4Swims America Corp20230—
+8K230037BACK 3Swims America Corp20230—
+8K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+8K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+8K223680Eneka ProTermosalud20230—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K212891TempSure SystemCynosure, LLC20221—
+8K213534PHantom TrilogyResurgeonz, LLC20220—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K213344BTL-899ABTL Industries, Inc.20222—
+8K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K193266MIINMedico USA, Inc.20210—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K201406PicowonWontech Co., Ltd.20200—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200104OxylightRaja Trading Company, Inc.202024—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K171227StarWalkerFotona D.O.O.20177—