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
+1K100893Cheveux Diode Laser SystemSandstone Medical Technologies, LLC20108—
+1K083848Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd.2009125—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K073300Milesman PremiumMilesman S.L.20076—
+1K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+1K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+1K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+1K030805Mythos 500Msq (M2), Ltd.2003363—
+1K020849Apex 800 Laser System, Model Apex 800Iridex Corp2002174—
+1K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001174—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K203804Global Med Systems Milesman Compact LaserGlobal Med Systems SL20210—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K183122810nm Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20190—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K141237Harmony LiteAlma, Inc.20154—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+2K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+2K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+2K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K053527Spectra Hair Removal LaserSpectragenics, Inc.2008169—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+2K052848Spectra Hair Removal LaserSpectragenics, Inc.2005172—
+2K052874Soprano Hair Removal Diode LaserMsq (M2), Ltd.2005126—
+2K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003173—
+3K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K233143PiXel8-RevealRohrer Aesthetics20240—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K22079410PLTentech Co., Ltd.20220—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K200616E>EyeCE-Swin20200—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K193426Elite iQCynosure, LLC20201—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+3K180508Joule SystemSciton, Inc20183—
+3K173285Joule SystemSciton, Inc20185—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K172413MT ONEM&T S.R.L.20175—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+3K152714Quanta ForteQuanta System Spa201513—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K123257Emvera DioluxEmvera Technologies, Inc.20123—
+3K113115Epicare YagLight Age, Inc.20120—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—