510(k) Report

Devices descending from K982940

1,526 later devices reach Lightsheer Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+1K090762LEDAQuantel Derma GmbH200946—
+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—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+1K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001174—
+1K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+1K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258—
+1K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.20001,492—
+2K200104OxylightRaja Trading Company, Inc.202024—
+2K170970EpilaserEpilady 2000, LLC20172—
+2K161503ORIONYerim Engineering Co., Ltd.20161—
+2K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+2K142845SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd.201511—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+2K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+2K131649MESyneron Beauty, Ltd.2013125—
+2K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+2K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+2K120737Tria Laser Hair Removal SystemTria Beauty, Inc.2012130—
+2K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+2K103560Shaser Ipl Hair Removal SystemShaser, Inc.2011140—
+2K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+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—
+2K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+2K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+2K042474ARIONWavelight Laser Technologie AG2004114—
+2K041262Duralite-GLLaser Scientific20040—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+2K031680SpectrapulsePrimary Technology, LLC20030—
+2K023881Profile 1064 Laser SystemSciton, Inc2003227—
+2K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+2K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+2K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+2K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc.20031,117—
+2K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+2K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+2K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+2K023081Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Medical Bio Care Sweden AB200223—
+2K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K021149Aurora DSSyneron Medical, Ltd.2002750—
+2K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc.20021,018—
+2K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+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—
+3K233224Epilaser ProEpilady 2000, LLC20240—
+3K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+3K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K230025IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd20230—
+3K230090Diode Laser Hair RemovalWuhan Lotuxs Technology 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—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+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—
+3K180224Element-TLElemenic Co., Ltd.20180—
+3K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+3K171702Exciplex308nmClarteis20175—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+3K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+3K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—