510(k) Report

Devices descending from K022839

251 later devices reach Fotona Dualis Plus ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+1K040384Mydon CWavelight Laser Technologie AG200451—
+2K170850Alma QAlma Lasers, Ltd.20172—
+2K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+2K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+2K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+2K090762LEDAQuantel Derma GmbH200946—
+2K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+2K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+3K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+3K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+3K171227StarWalkerFotona D.O.O.20177—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K213267Dynamis Pro FamilyFotona D.O.O.20222—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K202172StarWalkerFotona D.O.O.20203—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+4K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K171702Exciplex308nmClarteis20175—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K161669Waterlase ExpressBiolase, Inc.201621—
+4K152737Lite TouchFocus Medical, LLC20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K152012EVO platformQuanta System Spa201537—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K253765Vanish ProDdc Technologies, Inc.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241527Pastelle ProWontech Co., Ltd.20253—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240752Deka ToroEl.En S.P.A.20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—