510(k) Report

Devices descending from K083889

166 later devices reach Fotona QX ND:Yag/KTP Laser System Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+1K202288FinebeamSNJ Co., Ltd.20212—
+1K202172StarWalkerFotona D.O.O.20203—
+1K171227StarWalkerFotona D.O.O.20177—
+1K152012EVO platformQuanta System Spa201537—
+1K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+1K103455Spectra Laser SystemLutronic Corporation201192—
+2K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+2K253765Vanish ProDdc Technologies, Inc.20260—
+2K253342PICO-KSpeclipse, Inc.20251—
+2K253344Bellus-QSpeclipse, Inc.20250—
+2K250165PastelleWontech Co., Ltd.20250—
+2K241527Pastelle ProWontech Co., Ltd.20253—
+2K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+2K240752Deka ToroEl.En S.P.A.20240—
+2K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+2K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+2K160368EVO platformQuanta System Spa201636—
+2K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+2K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+2K113588Spectra Laser SystemLutronic Corporation201282—
+3K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+3K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+3K231054V-LaserWontech Co., Ltd.20231—
+3K223540AvalancheLase FamilyFotona D.O.O.20230—
+3K213267Dynamis Pro FamilyFotona D.O.O.20222—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K203788DermaV Laser SystemLutronic Corporation202101
+3K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+3K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+3K183156V-LaserWontech Co., Ltd.20193—
+3K181518Sebacia MicroparticlesSebacia, Inc.20180—
+3K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K171648BM.IrisBluecore Co., Ltd.20172—
+3K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+3K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+3K163222Discovery Pico FamilyQuanta System Spa201630—
+3K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+3K140837Lucid LYBio-Med USA, Inc.20140—
+3K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+3K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+4K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+4K252723Dynamis Pro FamilyFotona D.O.O.20260—
+4K251094Alma VeilWontech Co., Ltd.20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243488Vmat ProTermosalud20250—
+4K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K221865BTL-094BTL Industries, Inc.20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K210166Omnispec ED1000Medispec, Ltd.20230—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+4K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K212082PicoreBio-Med USA, Inc.20210—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+4K193266MIINMedico USA, Inc.20210—
+4K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+4K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+4K173700PICOPLUS Laser SystemLutronic Corporation20187—
+4K173199PicoSure WorkstationCynosure, Inc.20189—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+4K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+4K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+4K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+4K152856Helios IIILaseroptek Co., Ltd.20165—
+4K160480PicoSure WorkstationCynosure, Inc.201620—
+4K143105Picosure WorkstationCynosure, Inc.201549—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+5K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K253123CuRAS hybridClassys, Inc.20250—
+5K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+5K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+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—
+5K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+5K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212663Helios IV 785Laseroptek Co., Ltd.20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—