510(k) Report

Devices descending from K013034

800 later devices reach Modification to: Thermacool Iia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K243854Contour Light (CL-100)Contour Research, LLC20261—
+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—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K232236EchoQuanta System Spa20230—
+9K230467BTL-899FBTL Industries, Inc.20231—
+9K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+9K223292TempSure SystemCynosure, LLC20220—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K203788DermaV Laser SystemLutronic Corporation202101