510(k) Report

Devices descending from K053628

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+6K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+6K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+6K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+6K202172StarWalkerFotona D.O.O.20203—
+6K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K160368EVO platformQuanta System Spa201636—
+6K152012EVO platformQuanta System Spa201537—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+7K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+7K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+7K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+7K201773PicohiHironic Co., Ltd.20215—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—