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
+3K041262Duralite-GLLaser Scientific20040—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+3K031680SpectrapulsePrimary Technology, LLC20030—
+3K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+3K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+3K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc.20031,117—
+3K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+3K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+3K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+3K023081Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Medical Bio Care Sweden AB200223—
+3K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+3K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+3K021149Aurora DSSyneron Medical, Ltd.2002750—
+3K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc.20021,018—
+4K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+4K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+4K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+4K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K250384IPL400El Global Trade, Ltd.20250—
+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—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs 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—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+4K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+4K200616E>EyeCE-Swin20200—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K191086ExciplexClarteis20194—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+4K180508Joule SystemSciton, Inc20183—
+4K180224Element-TLElemenic Co., Ltd.20180—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+4K172413MT ONEM&T S.R.L.20175—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+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—
+4K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+4K141555AdvantageLutronic Corporation201414—
+4K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+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—
+4K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+4K131870Glide DeviceHome Skinovations, Ltd.201333—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K122493GenesisplusCutera, Inc.201318—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—