510(k) Report

Devices descending from K013034

800 later devices reach Modification to: Thermacool Iia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070004AccentAlma Lasers, Ltd.2007181—
+1K043402Thermage Thermacool SystemThermage, Inc.2005124—
+1K033942Thermage Thermacool SystemThermage, Inc.2004527—
+1K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+1K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+2K192621Medical RFTriworks Group Srl20200—
+2K133405MinnieElettronica Valseriana Srl20140—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+2K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+2K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+2K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+2K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+2K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+2K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+2K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+2K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+2K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+2K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+2K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+2K052936Thermage Thermacool SystemThermage, Inc.2007103—
+2K060948Portrait PSR3Rhytec Incorporated20061101
+2K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+2K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+2K040135Thermage Thermacool SystemThermage, Inc.2004496—
+2K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+2K031046Thermacool TC SystemThermage, Inc.200322—
+2K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+2K030142Thermacool TC SystemThermage, Inc.2003773—
+3K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+3K222556BTL-785XBTL Industries, Inc.20235—
+3K211639BTL-785WBTL Industries, Inc.20227—
+3K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+3K193201BTL-785FBtl20208—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K162547Viveve SystemViveve, Inc.20166—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+3K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K122966XP200Btl Industries, Ltd.20131—
+3K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K120513Glow by EndymedEndymed Medical, Ltd.20125—
+3K111026ApolloPollogen, Ltd.201114—
+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—
+3K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+3K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+3K071786Portrait PSRRhytec Incorporated2007109—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+3K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+3K031671Polaris WRSyneron Medical, Ltd.2003678—
+4K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+4K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K240311JETT Medical IICompex, Spol, S.R.O.20250—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K233849BTL-499BTL Industries, Inc.20240—
+4K233604BTL-785SBTL Industries, Inc.20243—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K23299210THERMATentech, Inc.20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221989The OligioWontech Co., Ltd.20222—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K180584Viveve RF System, SecureViveve, Inc.20185—
+4K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K162512truSculptCutera, Inc.20165—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K143109XP300BTL Industries, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+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—