510(k) Report

Devices descending from K000944

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+3K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+3K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+3K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+3K031671Polaris WRSyneron Medical, Ltd.2003678—
+3K030186Polris LVSyneron Medical, Ltd.2003680—
+4K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+4K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240070Profound MatrixCandela Corporation20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K233849BTL-499BTL Industries, Inc.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K233604BTL-785SBTL Industries, Inc.20243—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K23299210THERMATentech, Inc.20230—
+4K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K221989The OligioWontech Co., Ltd.20222—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K210077MED RF 4000F Care Systems USA, LLC20211—
+4K211217Profound MatrixCandela Corporation20210—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K203054FlexSysGme German Medical Engineering GmbH20210—
+4K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+4K200472Viveve SystemViveve Medical, Inc.20202—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191693BC-5Reveallux, Corp20190—
+4K183708Poly ClearMedtek Skincare, LLC201922—
+4K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+4K190422Viveve System 2.0Viveve Medical20194—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+4K180872Scarlet SRFVIOL Co., Ltd.20184—
+4K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K173285Joule SystemSciton, Inc20185—
+4K172023CelfirmVIOL Co., Ltd.20173—
+4K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160880Photonica ProfessionalWard Photonics, LLC20166—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+4K153229SuperbiumBios S.R.L.20162—
+4K153081Clear Bi-LightMichael Todd, LP201646—
+4K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K140386Lumina 24Rogers Sciences, Inc.20150—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143109XP300BTL Industries, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+4K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K120510TranscendSyneron Medical, Ltd.201318—
+4K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K130283Evrf SystemF Care Systems NV20132—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K121435Silkn BlueHome Skinovations, Ltd.2013125—
+4K122237Biophotas LifelightBiophotas, Inc.201371—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—