510(k) Report

Devices descending from K001746

714 later devices reach Lightsheer Pulsed Diode Array Laser System (Family of Products) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+1K090762LEDAQuantel Derma GmbH200946—
+1K083848Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd.2009125—
+1K053527Spectra Hair Removal LaserSpectragenics, Inc.2008169—
+1K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+1K052848Spectra Hair Removal LaserSpectragenics, Inc.2005172—
+1K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003173—
+1K030805Mythos 500Msq (M2), Ltd.2003363—
+1K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001174—
+2K200104OxylightRaja Trading Company, Inc.202024—
+2K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+2K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+2K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+2K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+2K082298Flash N' GOHome Skinovations, Ltd.2008168—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006171—
+2K052874Soprano Hair Removal Diode LaserMsq (M2), Ltd.2005126—
+2K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+3K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+3K192856MT OneM&T S.R.L.20202—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+3K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+3K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+3K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K171702Exciplex308nmClarteis20175—
+3K170970EpilaserEpilady 2000, LLC20172—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+3K142845SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd.201511—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+3K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K131649MESyneron Beauty, Ltd.2013125—
+3K130315Ipulse Hair Removal SystemCyden Limited2013124—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K123257Emvera DioluxEmvera Technologies, Inc.20123—
+3K122280Ipulse Smoothskin Hair Removal SystemCyden Limited2012125—
+3K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+3K120737Tria Laser Hair Removal SystemTria Beauty, Inc.2012130—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K103560Shaser Ipl Hair Removal SystemShaser, Inc.2011140—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K072906SILK'NHome Skinovations, Ltd.2008169—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+4K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+4K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+4K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K250384IPL400El Global Trade, Ltd.20250—