510(k) Report

Devices descending from K033942

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+1K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+1K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+1K070004AccentAlma Lasers, Ltd.2007181—
+1K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+1K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+1K043402Thermage Thermacool SystemThermage, Inc.2005124—
+2K222556BTL-785XBTL Industries, Inc.20235—
+2K211639BTL-785WBTL Industries, Inc.20227—
+2K192621Medical RFTriworks Group Srl20200—
+2K193201BTL-785FBtl20208—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K133405MinnieElettronica Valseriana Srl20140—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K122966XP200Btl Industries, Ltd.20131—
+2K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+2K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+2K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+2K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+2K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+2K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+2K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+2K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+2K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+2K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+2K052936Thermage Thermacool SystemThermage, Inc.2007103—
+2K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+3K250852CoolfaseAsterasys Co., Ltd.20250—
+3K251327XERFLutronic Corporation202501
+3K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+3K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+3K242241SunnyShenB Co., Ltd.20250—
+3K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+3K242688Finiff SystemSkingrab Co., Ltd.20240—
+3K240248Volnewmer™Classys, Inc.20241—
+3K233849BTL-499BTL Industries, Inc.20240—
+3K233604BTL-785SBTL Industries, Inc.20243—
+3K23299210THERMATentech, Inc.20230—
+3K230663DensityJeisys Medical, Inc.20232—
+3K221989The OligioWontech Co., Ltd.20222—
+3K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K143109XP300BTL Industries, Inc.20150—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+3K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+3K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+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—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+3K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K253504Volnewmer™Classys, Inc.20260—
+4K253750BTL-785NEHBTL Industries, Inc.20260—
+4K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K243488Vmat ProTermosalud20250—
+4K240311JETT Medical IICompex, Spol, S.R.O.20250—
+4K242532BTL-785BNF-EBTL Industries, Inc.20241—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K221865BTL-094BTL Industries, Inc.20230—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K210166Omnispec ED1000Medispec, Ltd.20230—
+4K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K171359Pollogen Legend+ SystemPollogen, Ltd.20174—