510(k) Report

Devices descending from K053628

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K123257Emvera DioluxEmvera Technologies, Inc.20123—
+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—
+4K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+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—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+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—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+4K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+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—
+4K161981Olive PlusAma Network, Inc.20160—
+4K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+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—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+5K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+5K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+5K193266MIINMedico USA, Inc.20210—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+5K201406PicowonWontech Co., Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+5K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182604New EraStep UP Skin Laser, LLC201801
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171227StarWalkerFotona D.O.O.20177—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—