510(k) Report

Devices descending from K973324

1,535 later devices reach Starlight Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+5K232236EchoQuanta System Spa20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+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—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+5K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+5K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K172181micro IPLEl Global Trade, Ltd.20170—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K170269Hee HR MiniOriental Inspiration Limited201713—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+5K161089sensiLight MiniEl Global Trade, Ltd.20164—
+5K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K152790Venus Versa SystemVenus Concept, Ltd.20160—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152012EVO platformQuanta System Spa201537—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K150336Photonica ProfessionalWard Photonics, LLC20157—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K141242Glide DeviceHome Skinovations, Ltd.201419—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K134017GigalaserPowermedic Aps20141—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130199Clarity LPC Laser SystemLutronic Corporation20135—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+5K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K120460SmartluxMedmix Co., Ltd.201218—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K113115Epicare YagLight Age, Inc.20120—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+5K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+5K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—