510(k) Report

Devices descending from K000944

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232236EchoQuanta System Spa20230—
+7K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230293TheraFace MaskTherabody, Inc.202316—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+7K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+7K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+7K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+7K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K203013AGNESAgnes Medical Co., Ltd.20224—
+7K221407truSculpt iDCutera, Inc.20222—
+7K212472AgeJetTriworks Group Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+7K212155TheraFace LEDTheragun, Inc.202142—
+7K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+7K212238TheraFace MicrocurrentTheragun, Inc.20210—
+7K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+7K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+7K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+7K202199BTL-899STBtl20216—
+7K193266MIINMedico USA, Inc.20210—
+7K202172StarWalkerFotona D.O.O.20203—
+7K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K200241TempSure SystemCynosure, LLC202013—
+7K192430Epic 980Biolase, Inc.20195—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K190443MMSphereGalactic Beauty, LLC201942—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K170984LG Beauty Led MaskLg Electronics201793—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+7K160691Acne Light Therapy WandZuko, Inc.201650—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—