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
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140120EPIC 10Biolase, Inc.20141—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+5K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+5K140527Sensilight MiniEl Global Trade, Ltd.201423—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K131870Glide DeviceHome Skinovations, Ltd.201333—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K123845MESyneron Beauty, Ltd.2013126—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+5K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+5K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K094049Stlase Diode LaserDental Photonics, Inc.201023—
+5K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+6K261975Braun Aura 7 (6041)CyDen Limited20260—
+6K261977Braun Aura 9 (6042)Cyden Limited20260—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+6K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+6K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+6K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+6K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242349FoLixLumenis Be, 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—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+6K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., 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—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+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—
+6K192430Epic 980Biolase, Inc.20195—