510(k) Report

Devices descending from K001746

714 later devices reach Lightsheer Pulsed Diode Array Laser System (Family of Products) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+4K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+4K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+4K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+4K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+4K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K233224Epilaser ProEpilady 2000, LLC20240—
+4K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+4K230025IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd20230—
+4K230090Diode Laser Hair RemovalWuhan Lotuxs Technology Co., Ltd.20230—
+4K223680Eneka ProTermosalud20230—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K22079410PLTentech Co., Ltd.20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+4K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+4K200616E>EyeCE-Swin20200—
+4K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+4K191086ExciplexClarteis20194—
+4K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+4K172413MT ONEM&T S.R.L.20175—
+4K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+4K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K161981Olive PlusAma Network, Inc.20160—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152714Quanta ForteQuanta System Spa201513—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+4K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+4K141986Elux 810 LaserEquipmed North America, Inc.20150—
+4K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+4K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+4K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+4K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+4K140527Sensilight MiniEl Global Trade, Ltd.201423—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K131870Glide DeviceHome Skinovations, Ltd.201333—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123845MESyneron Beauty, Ltd.2013126—
+4K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K261975Braun Aura 7 (6041)CyDen Limited20260—
+5K261977Braun Aura 9 (6042)Cyden Limited20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—