510(k) Report

Devices descending from K003183

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212891TempSure SystemCynosure, LLC20221—
+8K213534PHantom TrilogyResurgeonz, LLC20220—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+8K211107BTL-899 FPBTL Industries, Inc.20213—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K193266MIINMedico USA, Inc.20210—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K201406PicowonWontech Co., Ltd.20200—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200104OxylightRaja Trading Company, Inc.202024—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K171227StarWalkerFotona D.O.O.20177—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170709CURVE Laser SystemYolo Medical, Inc.20170—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K160470SculpSureCynosure, Inc.201620—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+8K151629Guardian 1000Quanta System Spa20150—
+8K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140120EPIC 10Biolase, Inc.20141—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+8K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K121286EPIC 10Biolase Technology, Inc.201231—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+8K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+8K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+8K092734E-Light LineEspansione Marketing S.P.A20102—
+8K094049Stlase Diode LaserDental Photonics, Inc.201023—
+8K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+8K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+9K243854Contour Light (CL-100)Contour Research, LLC20261—
+9K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+9K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+9K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+9K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+9K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+9K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+9K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+9K241656Eneka SelectifTermosalud20241—
+9K240780InMode RF SystemInMode, Ltd.20243—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K233344Regenalase Laser SystemIpg Medical20240—