510(k) Report

Devices descending from K981952

763 later devices reach Combination ND:Yag and Frequency Doubled Solid State Green Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K063074Candela 3630 Laser SystemCandela Corp.2006179—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+4K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+4K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+4K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K232236EchoQuanta System Spa20230—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K192856MT OneM&T S.R.L.20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K171227StarWalkerFotona D.O.O.20177—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K153229SuperbiumBios S.R.L.20162—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152012EVO platformQuanta System Spa201537—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133774AtovenBio-Med USA, Inc.20146—