510(k) Report

Devices descending from K053628

351 later devices reach Lightsheer Duet Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+1K151947LightSheer Desire Light Laser SystemLumenis, Ltd.201527—
+1K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+1K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+1K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+1K113502Advantage Laser SystemLutronic Corporation201215—
+1K111851Mediostar NextAsclepion Laser Technologies GmbH201133—
+1K083848Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd.2009125—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+2K232236EchoQuanta System Spa20230—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K213261EpilMENeauvia North America20220—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+2K192856MT OneM&T S.R.L.20202—
+2K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+2K193367elysion-proHigh Technology Products S.L.U20203—
+2K193426Elite iQCynosure, LLC20201—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K173677InMode VLazeInmode MD, Ltd.20183—
+2K170738InMode Diolaze XLInmode MD, Ltd.201715—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+2K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+2K153229SuperbiumBios S.R.L.20162—
+2K153566Magma SystemFormatk Systems, Ltd.20162—
+2K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+2K141237Harmony LiteAlma, Inc.20154—
+2K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+2K141555AdvantageLutronic Corporation201414—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+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—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K241656Eneka SelectifTermosalud20241—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+3K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K223680Eneka ProTermosalud20230—
+3K22079410PLTentech Co., Ltd.20220—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K222369PURE LaserEndymed Medical, Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K200616E>EyeCE-Swin20200—
+3K200786Venus EpileveVenus Concept USA, Inc.20200—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+3K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+3K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+3K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+3K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+3K180508Joule SystemSciton, Inc20183—
+3K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+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—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162781Magma SparkFormatk Systems, Ltd.20160—
+3K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+3K152714Quanta ForteQuanta System Spa201513—
+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—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—