510(k) Report

Devices descending from K000944

1,069 later devices reach Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+5K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K202415VirtueRFShenB Co., Ltd.20213—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K200616E>EyeCE-Swin20200—
+5K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+5K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+5K200185Sylfirm XVIOL Co., Ltd.20202—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+5K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+5K182365TempSure SystemCynosure, Inc.201815—
+5K180338CellulizeWard Photonics, LLC20182—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K181659Avologi ENEOPremier North America, Inc.20184—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+5K180508Joule SystemSciton, Inc20183—
+5K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+5K180320dpl IIa PanelLed Technologies, Inc.201814—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172111Vevazz LEDVevazz, LLC20170—
+5K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+5K171702Exciplex308nmClarteis20175—
+5K172413MT ONEM&T S.R.L.20175—
+5K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+5K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+5K163415SlimShape SystemSyneron Medical, Ltd.201714—
+5K162784Silk'n HSTHome Skinovations, Ltd.20171—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+5K162512truSculptCutera, Inc.20165—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+5K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+5K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K143554Venus Legacy CXVenus Concept, Ltd.201517—
+5K143559XP1000 RFBTL Industries, Inc.20157—
+5K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150035V10 systemViora, Ltd.201531—
+5K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140471Pro X Otc 5La Lumiere, LLC2015107—
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K141904Viora V-TouchViora, Ltd.20140—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+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—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+5K131758Surgen UPollogen, Ltd.20135—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+5K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K122579VelashapeSyneron Medical, Ltd.20124—