510(k) Report

Devices descending from K030142

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K230167BACK 4Swims America Corp20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K230037BACK 3Swims America Corp20230—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K223680Eneka ProTermosalud20230—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K22079410PLTentech Co., Ltd.20220—
+6K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K221407truSculpt iDCutera, Inc.20222—
+6K210084SilkroHironic Co., Ltd.20223—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K213534PHantom TrilogyResurgeonz, LLC20220—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K202199BTL-899STBtl20216—
+6K201685PotenzaJeisys Medical, Inc.20219—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K201735PlaDuo SystemShenB Co., Ltd.20203—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+6K200616E>EyeCE-Swin20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+6K172413MT ONEM&T S.R.L.20175—
+6K171262TempSureCynosure, Inc.201716—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170709CURVE Laser SystemYolo Medical, Inc.20170—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161661Thermi RF AccessoriesThermi20163—
+6K160470SculpSureCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K151793InMode RF SystemInmode MD, Ltd.20161—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K140120EPIC 10Biolase, Inc.20141—
+6K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—