510(k) Report

Devices descending from K033942

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+7K223680Eneka ProTermosalud20230—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K223110truSculpt iDCutera, Inc.20221—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K212472AgeJetTriworks Group Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K211107BTL-899 FPBTL Industries, Inc.20213—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K200241TempSure SystemCynosure, LLC202013—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171227StarWalkerFotona D.O.O.20177—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160470SculpSureCynosure, Inc.201620—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K150724SculpSureCynosure, Inc.201521—
+7K150230SculpSureCynosure, Inc.201521—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K254185Potenza PrimeJeisys Medical Incorporated20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+8K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+8K253803MILAN SystemLumenis Be, Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+8K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+8K251254Ignite RF SystemInMode, Ltd.20260—
+8K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+8K252367InbellaMulti SystemInbella Medical, Inc.20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K233766Geneo X ElitePollogen, Ltd.20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K233642InMode RF SystemInMode, Ltd.20244—
+8K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K212891TempSure SystemCynosure, LLC20221—