510(k) Report

Devices descending from K003183

833 later devices reach Thermage Thermacool II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K130283Evrf SystemF Care Systems NV20132—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+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—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+4K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+4K090221Reaction SystemViora, Ltd.200954—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K072394Portrait Stand-OffRhytec Incorporated2007104—
+4K071872VelashapeSyneron Medical, Ltd.2007127—
+4K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K061603SmoothshapesBiocellulase, Inc.200648—
+4K053611SmoothshapesBicellulase, Inc.200695—
+4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+4K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+5K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+5K253750BTL-785NEHBTL Industries, Inc.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+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—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, 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—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K221873NeoGen PSR SystemEnergist Limited20230—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K202415VirtueRFShenB Co., Ltd.20213—
+5K200472Viveve SystemViveve Medical, Inc.20202—
+5K192856MT OneM&T S.R.L.20202—
+5K200185Sylfirm XVIOL Co., Ltd.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K190422Viveve System 2.0Viveve Medical20194—
+5K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+5K182365TempSure SystemCynosure, Inc.201815—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K163415SlimShape SystemSyneron Medical, Ltd.201714—
+5K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+5K162512truSculptCutera, Inc.20165—
+5K161661Thermi RF AccessoriesThermi20163—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K143554Venus Legacy CXVenus Concept, Ltd.201517—
+5K143559XP1000 RFBTL Industries, Inc.20157—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150035V10 systemViora, Ltd.201531—
+5K141237Harmony LiteAlma, Inc.20154—
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K141904Viora V-TouchViora, Ltd.20140—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+5K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+5K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—