510(k) Report

Devices descending from K000944

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130689Symphony RF GeneratorThermigen, Inc.201311—
+1K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+1K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+1K043402Thermage Thermacool SystemThermage, Inc.2005124—
+1K033942Thermage Thermacool SystemThermage, Inc.2004527—
+1K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+1K022266Aurora SRSyneron Medical, Ltd.2002705—
+1K021149Aurora DSSyneron Medical, Ltd.2002750—
+1K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+1K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+2K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+2K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+2K162547Viveve SystemViveve, Inc.20166—
+2K161661Thermi RF AccessoriesThermi20163—
+2K151793InMode RF SystemInmode MD, Ltd.20161—
+2K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+2K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+2K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+2K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+2K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+2K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+2K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+2K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+2K052936Thermage Thermacool SystemThermage, Inc.2007103—
+2K070004AccentAlma Lasers, Ltd.2007181—
+2K060948Portrait PSR3Rhytec Incorporated20061101
+2K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+2K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+2K040135Thermage Thermacool SystemThermage, Inc.2004496—
+2K031489PitangaSyneron Medical, Ltd.20030—
+2K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+2K031988Aurora DSSyneron Medical, Ltd.2003450—
+2K031993Aurora SRSyneron Medical, Ltd.2003303—
+2K030426Omnilux RedPhoto Therapeutics Limited2003563—
+2K031046Thermacool TC SystemThermage, Inc.200322—
+2K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+2K024064Polaris DSSyneron Medical, Ltd.2003681—
+2K030142Thermacool TC SystemThermage, Inc.2003773—
+3K222556BTL-785XBTL Industries, Inc.20235—
+3K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+3K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+3K211639BTL-785WBTL Industries, Inc.20227—
+3K192621Medical RFTriworks Group Srl20200—
+3K193201BTL-785FBtl20208—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K180584Viveve RF System, SecureViveve, Inc.20185—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K170116Thermi Injectable RF ElectrodesThermi20172—
+3K162851eLyx-PROIntelligent Sensory Concept SA20170—
+3K163190InMode RF SystemInmode MD, Ltd.20160—
+3K161043Profound SystemSyneron Candela Corporation20160—
+3K150336Photonica ProfessionalWard Photonics, LLC20157—
+3K133405MinnieElettronica Valseriana Srl20140—
+3K134017GigalaserPowermedic Aps20141—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K121481Infini Radiofrequency SystemLutronic Corporation201357—
+3K122966XP200Btl Industries, Ltd.20131—
+3K120460SmartluxMedmix Co., Ltd.201218—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+3K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+3K090762LEDAQuantel Derma GmbH200946—
+3K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+3K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+3K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+3K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+3K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+3K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+3K073000LumaprobeClareblend, Inc.20080—
+3K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+3K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+3K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+3K071786Portrait PSRRhytec Incorporated2007109—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+3K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+3K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+3K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+3K051255Lumiphase-ROpusmed, Inc.2005143—
+3K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+3K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—