510(k) Report

Devices descending from K002421

744 later devices reach Candela Mid IR Diode Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+6K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+6K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253765Vanish ProDdc Technologies, Inc.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250165PastelleWontech Co., Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K241527Pastelle ProWontech Co., Ltd.20253—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K221761SoleaConvergent Dental, Inc.202201
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K213594Echolaser X4Elesta S.P.A20221—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K213428EdgeProBiolase, Inc.20210—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K193201BTL-785FBtl20208—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K182173Joule SystemSciton, Inc20195—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K171702Exciplex308nmClarteis20175—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K171009LASEMD Laser SystemLutronic Corporation20178—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—