510(k) Report

Devices descending from K030142

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K250165PastelleWontech Co., Ltd.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K231216PotenzaJeisys Medical, Inc.20244—
+7K231287PotenzaJeisys Medical, Inc.20241—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K233123SilkroHironic Co., Ltd.20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K240999Legend X Applicator VOPollogen, Ltd.20241—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K230837PlazMagikAgnes Medical Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232223PlaDuo SystemShenB Co., Ltd.20230—
+7K232236EchoQuanta System Spa20230—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+7K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+7K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K223110truSculpt iDCutera, Inc.20221—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K212472AgeJetTriworks Group Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K211681EONDominion Aesthetic Technologies, Inc.20221—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K212331BodySculpRohrer Aesthetics, LLC20211—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+7K211107BTL-899 FPBTL Industries, Inc.20213—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K202172StarWalkerFotona D.O.O.20203—
+7K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192430Epic 980Biolase, Inc.20195—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—