510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+4K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070004AccentAlma Lasers, Ltd.2007181—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+4K063249BeamaxMedic Sharplight, Ltd.200758—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+4K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+4K062369Iridex Oculight TXIridex Corp200673—
+4K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+4K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+4K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+4K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K053324Chromolite SystemChromogenex Plc200631—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+4K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+4K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+4K043032Dealight IplEuropro, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K051255Lumiphase-ROpusmed, Inc.2005143—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+4K041969Aurora DSSyneron Medical, Ltd.2004302—
+4K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+4K033933Powerlite 600 EX SystemPreswede AB20040—
+4K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+4K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+4K030186Polris LVSyneron Medical, Ltd.2003680—
+5K261975Braun Aura 7 (6041)CyDen Limited20260—
+5K261977Braun Aura 9 (6042)Cyden Limited20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+5K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K22079410PLTentech Co., Ltd.20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+5K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K202172StarWalkerFotona D.O.O.20203—
+5K192621Medical RFTriworks Group Srl20200—