510(k) Report

Devices descending from K011939

237 later devices reach Fotona Dualis, Fotona Dualis Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202172StarWalkerFotona D.O.O.20203—
+1K171227StarWalkerFotona D.O.O.20177—
+1K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+1K020697Depilase Twin Yag Laser SystemDepilase Group, Ltd.2002229—
+2K253342PICO-KSpeclipse, Inc.20251—
+2K253344Bellus-QSpeclipse, Inc.20250—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+3K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K090762LEDAQuantel Derma GmbH200946—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K152012EVO platformQuanta System Spa201537—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+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—
+6K223680Eneka ProTermosalud20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+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—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K213594Echolaser X4Elesta S.P.A20221—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K171702Exciplex308nmClarteis20175—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—