510(k) Report

Devices descending from K981351

811 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K080735CryominiZimmer Elektromedizin GmbH20081—
+5K072344Apl Medical SystemBios S.R.L.20076—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+5K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K052354Oculase MDBiolase Technology, Inc.20065—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K223680Eneka ProTermosalud20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+6K22079410PLTentech Co., Ltd.20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K213594Echolaser X4Elesta S.P.A20221—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202172StarWalkerFotona D.O.O.20203—
+6K200616E>EyeCE-Swin20200—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K171702Exciplex308nmClarteis20175—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—