510(k) Report

Devices descending from K974346

474 later devices reach Starlight Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+5K230025IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd20230—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K230090Diode Laser Hair RemovalWuhan Lotuxs Technology Co., Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+5K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+5K140527Sensilight MiniEl Global Trade, Ltd.201423—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K131870Glide DeviceHome Skinovations, Ltd.201333—
+5K123845MESyneron Beauty, Ltd.2013126—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+6K261975Braun Aura 7 (6041)CyDen Limited20260—
+6K261977Braun Aura 9 (6042)Cyden Limited20260—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo 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—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+6K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+6K242349FoLixLumenis Be, Ltd.20240—
+6K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+6K223680Eneka ProTermosalud20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+6K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K193266MIINMedico USA, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+6K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—