510(k) Report

Devices descending from K000944

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+6K221083Smartlux MiniMedmix Co., Ltd.20222—
+6K213612Sylfirm XVIOL Co., Ltd.20221—
+6K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+6K210084SilkroHironic Co., Ltd.20223—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K213534PHantom TrilogyResurgeonz, LLC20220—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K213814Viveve 2.0 SystemViveve, Inc.20220—
+6K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+6K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K211562Virtue RFShenB Co., Ltd.20212—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202780SectumNeauvia North America20211—
+6K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K201685PotenzaJeisys Medical, Inc.20219—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K201735PlaDuo SystemShenB Co., Ltd.20203—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K191086ExciplexClarteis20194—
+6K192224BTL-899Btl20198—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K192728AgnesAgnes Medical Co., Ltd.20196—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K190678TempSureCynosure, Inc.201914—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K183450EmBody SystemInmode MD, Ltd.20198—
+6K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+6K183247dpl FacewareLed Technologies, Inc.201910—
+6K183118dpl SpotLiteLed Technologies, Inc.201922—
+6K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K180875Poly RejuvMedtek Skincare, LLC20180—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+6K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+6K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+6K1718212 Face / Face EvolutionHeat IN A Click201858—
+6K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+6K171262TempSureCynosure, Inc.201716—
+6K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+6K171227StarWalkerFotona D.O.O.20177—
+6K172004truSculptCutera, Inc.20173—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K170068Softcure 96Wellray Medical Laser, Inc.20170—
+6K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+6K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+6K152731XP1100 RFBTL Industries, Inc.20160—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+6K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—