510(k) Report

Devices descending from K021402

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K233123SilkroHironic Co., Ltd.20241—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K232236EchoQuanta System Spa20230—
+8K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K223292TempSure SystemCynosure, LLC20220—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K223110truSculpt iDCutera, Inc.20221—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K212472AgeJetTriworks Group Srl20220—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K211107BTL-899 FPBTL Industries, Inc.20213—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K193266MIINMedico USA, Inc.20210—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K192430Epic 980Biolase, Inc.20195—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K171702Exciplex308nmClarteis20175—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K171111SculpsureCynosure, Inc.201710—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K170500SIROLaser Advance+Dentsply Sirona201721—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K124064Young AgainEspansione Marketing S.P.A20131—
+8K131839DC 7Dc International, LLC20130—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K111689StlaseDental Photonics, Inc.201222—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—