510(k) Report

Devices descending from K021402

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+7K202199BTL-899STBtl20216—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K200104OxylightRaja Trading Company, Inc.202024—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+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—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K171227StarWalkerFotona D.O.O.20177—
+7K170709CURVE Laser SystemYolo Medical, Inc.20170—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K160470SculpSureCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+7K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+7K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K140120EPIC 10Biolase, Inc.20141—
+7K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K092734E-Light LineEspansione Marketing S.P.A20102—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K241656Eneka SelectifTermosalud20241—