510(k) Report

Devices descending from K994014

1,283 later devices reach Esc Intense Pulsed Light Systems: Epilight and Multilight through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+3K073000LumaprobeClareblend, Inc.20080—
+3K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+3K080638CLAROClrs Technology Corporation20082—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K063249BeamaxMedic Sharplight, Ltd.200758—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+3K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+3K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+3K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+3K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+3K053324Chromolite SystemChromogenex Plc200631—
+3K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+3K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+3K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+3K043032Dealight IplEuropro, Inc.20050—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+3K051255Lumiphase-ROpusmed, Inc.2005143—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+3K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K040156Ifl Professional System, Model C100Cyden Limited20040—
+3K033933Powerlite 600 EX SystemPreswede AB20040—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K251094Alma VeilWontech Co., Ltd.20250—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K22079410PLTentech Co., Ltd.20220—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K203054FlexSysGme German Medical Engineering GmbH20210—
+4K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+4K202172StarWalkerFotona D.O.O.20203—
+4K192621Medical RFTriworks Group Srl20200—
+4K200616E>EyeCE-Swin20200—
+4K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—