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
+1K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+1K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001174—
+1K983950Ceralas Diode Laser System (Model H)Ceram Optec, Inc.19990—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K053527Spectra Hair Removal LaserSpectragenics, Inc.2008169—
+2K052848Spectra Hair Removal LaserSpectragenics, Inc.2005172—
+2K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003173—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K141237Harmony LiteAlma, Inc.20154—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K082298Flash N' GOHome Skinovations, Ltd.2008168—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006171—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K200616E>EyeCE-Swin20200—
+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—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K170970EpilaserEpilady 2000, LLC20172—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K142845SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd.201511—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K131649MESyneron Beauty, Ltd.2013125—
+4K130315Ipulse Hair Removal SystemCyden Limited2013124—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K122280Ipulse Smoothskin Hair Removal SystemCyden Limited2012125—
+4K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+4K120737Tria Laser Hair Removal SystemTria Beauty, Inc.2012130—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103560Shaser Ipl Hair Removal SystemShaser, Inc.2011140—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K072906SILK'NHome Skinovations, Ltd.2008169—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+5K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K250165PastelleWontech Co., Ltd.20250—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K250384IPL400El Global Trade, Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—