510(k) Report

Devices descending from K003614

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+3K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K082298Flash N' GOHome Skinovations, Ltd.2008168—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+3K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006171—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+4K250189AdvaTxAdvalight Aps20250—
+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—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K223680Eneka ProTermosalud20230—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200786Venus EpileveVenus Concept USA, Inc.20200—
+4K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+4K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170970EpilaserEpilady 2000, LLC20172—
+4K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K161981Olive PlusAma Network, Inc.20160—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K142845SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd.201511—
+4K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141986Elux 810 LaserEquipmed North America, Inc.20150—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131649MESyneron Beauty, Ltd.2013125—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130315Ipulse Hair Removal SystemCyden Limited2013124—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K122280Ipulse Smoothskin Hair Removal SystemCyden Limited2012125—
+4K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+4K120737Tria Laser Hair Removal SystemTria Beauty, Inc.2012130—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K103560Shaser Ipl Hair Removal SystemShaser, Inc.2011140—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—