510(k) Report

Devices descending from K022884

642 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K113588Spectra Laser SystemLutronic Corporation201282—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K223680Eneka ProTermosalud20230—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K221761SoleaConvergent Dental, Inc.202201
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+6K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K213428EdgeProBiolase, Inc.20210—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K182173Joule SystemSciton, Inc20195—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—