510(k) Report

Devices descending from K030142

773 later devices reach Thermacool TC System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+5K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K192856MT OneM&T S.R.L.20202—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K192224BTL-899Btl20198—
+5K191855EmFace DeviceInmode MD, Ltd.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+5K181095RF-ReliefEl Global Trade, Ltd.20181—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+5K180508Joule SystemSciton, Inc20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172302InMode PLUS SystemInmode MD, Ltd.201713—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K172004truSculptCutera, Inc.20173—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+5K152731XP1100 RFBTL Industries, Inc.20160—
+5K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K150724SculpSureCynosure, Inc.201521—
+5K150230SculpSureCynosure, Inc.201521—
+5K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K130689Symphony RF GeneratorThermigen, Inc.201311—
+5K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+5K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K102461FractoraInvasix, Ltd.201124—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090762LEDAQuantel Derma GmbH200946—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K090094Zeltiq SystemZeltiq Aesthetics200932—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K250734OptiLUV DevicePollogen, Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K250200InbellaBody SystemInbella Medical, Inc.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—