510(k) Report

Devices descending from K030142

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+1K033942Thermage Thermacool SystemThermage, Inc.2004527—
+1K031671Polaris WRSyneron Medical, Ltd.2003678—
+2K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+2K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+2K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+2K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+2K090221Reaction SystemViora, Ltd.200954—
+2K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+2K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+2K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+2K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+2K071872VelashapeSyneron Medical, Ltd.2007127—
+2K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K070004AccentAlma Lasers, Ltd.2007181—
+2K061603SmoothshapesBiocellulase, Inc.200648—
+2K053611SmoothshapesBicellulase, Inc.200695—
+2K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+2K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+2K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+2K043402Thermage Thermacool SystemThermage, Inc.2005124—
+2K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+3K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+3K222556BTL-785XBTL Industries, Inc.20235—
+3K211639BTL-785WBTL Industries, Inc.20227—
+3K192621Medical RFTriworks Group Srl20200—
+3K193201BTL-785FBtl20208—
+3K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K143554Venus Legacy CXVenus Concept, Ltd.201517—
+3K150035V10 systemViora, Ltd.201531—
+3K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+3K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+3K141904Viora V-TouchViora, Ltd.20140—
+3K133405MinnieElettronica Valseriana Srl20140—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+3K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K122966XP200Btl Industries, Ltd.20131—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K122579VelashapeSyneron Medical, Ltd.20124—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K120513Glow by EndymedEndymed Medical, Ltd.20125—
+3K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+3K111026ApolloPollogen, Ltd.201114—
+3K111784Venus Swan SystemVenus Concept, Ltd.20111—
+3K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+3K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+3K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K083629SmoothshapesEleme Medical, Inc.200927—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+3K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+4K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+4K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+4K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+4K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K233849BTL-499BTL Industries, Inc.20240—
+4K233604BTL-785SBTL Industries, Inc.20243—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K23299210THERMATentech, Inc.20230—
+4K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221989The OligioWontech Co., Ltd.20222—
+4K212561MTX-C1Ilooda Co,., Ltd.20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—