510(k) Report

Devices descending from K033942

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162512truSculptCutera, Inc.20165—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K141237Harmony LiteAlma, Inc.20154—
+4K142910Legacy BXVenus Concept USA, Inc.201411—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+4K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K102461FractoraInvasix, Ltd.201124—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K090094Zeltiq SystemZeltiq Aesthetics200932—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K243929Oligio XWontech Co., Ltd.20250—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+5K231146AliTightAlic Iotech, LLC20230—
+5K22079410PLTentech Co., Ltd.20220—
+5K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K200616E>EyeCE-Swin20200—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192224BTL-899Btl20198—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K172413MT ONEM&T S.R.L.20175—
+5K171262TempSureCynosure, Inc.201716—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K172004truSculptCutera, Inc.20173—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K161661Thermi RF AccessoriesThermi20163—
+5K152731XP1100 RFBTL Industries, Inc.20160—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K152714Quanta ForteQuanta System Spa201513—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K131758Surgen UPollogen, Ltd.20135—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—