510(k) Report

Devices descending from K010005

855 later devices reach Cynosure Photogenica DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024064Polaris DSSyneron Medical, Ltd.2003681—
+1K020849Apex 800 Laser System, Model Apex 800Iridex Corp2002174—
+2K053527Spectra Hair Removal LaserSpectragenics, Inc.2008169—
+2K052848Spectra Hair Removal LaserSpectragenics, Inc.2005172—
+2K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+2K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003173—
+2K030186Polris LVSyneron Medical, Ltd.2003680—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+3K082298Flash N' GOHome Skinovations, Ltd.2008168—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006171—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+3K031671Polaris WRSyneron Medical, Ltd.2003678—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K170970EpilaserEpilady 2000, LLC20172—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K153229SuperbiumBios S.R.L.20162—
+4K142845SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd.201511—
+4K141237Harmony LiteAlma, Inc.20154—
+4K131649MESyneron Beauty, Ltd.2013125—
+4K130315Ipulse Hair Removal SystemCyden Limited2013124—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K122280Ipulse Smoothskin Hair Removal SystemCyden Limited2012125—
+4K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+4K120737Tria Laser Hair Removal SystemTria Beauty, Inc.2012130—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K103560Shaser Ipl Hair Removal SystemShaser, Inc.2011140—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+4K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K072906SILK'NHome Skinovations, Ltd.2008169—
+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—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070004AccentAlma Lasers, Ltd.2007181—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+5K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+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—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+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—
+5K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+5K230025IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd20230—
+5K230090Diode Laser Hair RemovalWuhan Lotuxs Technology Co., Ltd.20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K192621Medical RFTriworks Group Srl20200—
+5K200616E>EyeCE-Swin20200—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+5K172413MT ONEM&T S.R.L.20175—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+5K152714Quanta ForteQuanta System Spa201513—
+5K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+5K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—