510(k) Report

Devices descending from K013639

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K120510TranscendSyneron Medical, Ltd.201318—
+4K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K122579VelashapeSyneron Medical, Ltd.20124—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+4K111026ApolloPollogen, Ltd.201114—
+4K111784Venus Swan SystemVenus Concept, Ltd.20111—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K102461FractoraInvasix, Ltd.201124—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+4K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K083629SmoothshapesEleme Medical, Inc.200927—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253750BTL-785NEHBTL Industries, Inc.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K243488Vmat ProTermosalud20250—
+5K240311JETT Medical IICompex, Spol, S.R.O.20250—
+5K242532BTL-785BNF-EBTL Industries, Inc.20241—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K212561MTX-C1Ilooda Co,., Ltd.20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+5K202780SectumNeauvia North America20211—
+5K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K192856MT OneM&T S.R.L.20202—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K190743Venus BlissVenus Concept USA, Inc.20194—
+5K183450EmBody SystemInmode MD, Ltd.20198—
+5K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+5K182365TempSure SystemCynosure, Inc.201815—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173285Joule SystemSciton, Inc20185—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K163415SlimShape SystemSyneron Medical, Ltd.201714—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K162512truSculptCutera, Inc.20165—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+5K161661Thermi RF AccessoriesThermi20163—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+5K153229SuperbiumBios S.R.L.20162—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K152611V20 systemViora, Ltd.20164—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K143559XP1000 RFBTL Industries, Inc.20157—