510(k) Report

Devices descending from K053365

203 later devices reach Modification to Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142833INTRAGenJeisys Medical, Inc.20150—
+1K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+1K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+1K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+1K070004AccentAlma Lasers, Ltd.2007181—
+1K060948Portrait PSR3Rhytec Incorporated20061101
+2K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+2K222556BTL-785XBTL Industries, Inc.20235—
+2K211639BTL-785WBTL Industries, Inc.20227—
+2K192621Medical RFTriworks Group Srl20200—
+2K193201BTL-785FBtl20208—
+2K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+2K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+2K133405MinnieElettronica Valseriana Srl20140—
+2K130501IntensifEndymed Medical, Ltd.201457—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+2K122966XP200Btl Industries, Ltd.20131—
+2K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+2K120513Glow by EndymedEndymed Medical, Ltd.20125—
+2K111026ApolloPollogen, Ltd.201114—
+2K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+2K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+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—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+2K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+2K071786Portrait PSRRhytec Incorporated2007109—
+3K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+3K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+3K233849BTL-499BTL Industries, Inc.20240—
+3K233604BTL-785SBTL Industries, Inc.20243—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K221571InMode Multi-systemInMode, 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—
+3K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+3K160312Fraxis DuoIlooda Co,., Ltd.201614—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+3K143109XP300BTL Industries, Inc.20150—
+3K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+3K111784Venus Swan SystemVenus Concept, Ltd.20111—
+3K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+3K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K072394Portrait Stand-OffRhytec Incorporated2007104—
+4K253750BTL-785NEHBTL Industries, Inc.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+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—
+4K242532BTL-785BNF-EBTL Industries, Inc.20241—
+4K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K23299210THERMATentech, Inc.20230—
+4K231146AliTightAlic Iotech, LLC20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221873NeoGen PSR SystemEnergist Limited20230—
+4K221989The OligioWontech Co., Ltd.20222—
+4K192545PotenzaJeisys Medical Incorporated202020—
+4K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+4K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+4K173503Pollogen Legend SystemPollogen, Ltd.20183—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K162512truSculptCutera, Inc.20165—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K142910Legacy BXVenus Concept USA, Inc.201411—
+4K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+4K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+5K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K240897CellinewVIOL Co., Ltd.20240—