510(k) Report

Devices descending from K020453

1,018 later devices reach Palomar Estelux Pulsed Light System and Palomar Coolroller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061720CosmelightPenntack Enterprises, Inc.20070—
+1K052336Spectraquattro Pulsed Light SystemAmjet Distribution, LLC20050—
+1K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+1K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+1K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+1K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+1K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+1K033946Lovely SystemMsq (M2), Ltd.2004737—
+1K040156Ifl Professional System, Model C100Cyden Limited20040—
+1K032460Profile BBL SystemSciton, Inc2003569—
+1K030426Omnilux RedPhoto Therapeutics Limited2003563—
+1K031680SpectrapulsePrimary Technology, LLC20030—
+1K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+1K030480L600 Hair RemovalA&M Technology20031—
+1K022607SpectrapulsePrimary Technology, LLC20020—
+2K200104OxylightRaja Trading Company, Inc.202024—
+2K162851eLyx-PROIntelligent Sensory Concept SA20170—
+2K150336Photonica ProfessionalWard Photonics, LLC20157—
+2K134017GigalaserPowermedic Aps20141—
+2K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+2K120460SmartluxMedmix Co., Ltd.201218—
+2K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+2K090724OR-LightYperion Technology20090—
+2K090762LEDAQuantel Derma GmbH200946—
+2K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+2K073000LumaprobeClareblend, Inc.20080—
+2K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+2K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+2K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+2K081578Accela SystemGenesis Biosystems, Inc.20080—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063249BeamaxMedic Sharplight, Ltd.200758—
+2K060792IllumimedPhotoactif, LLC2006115—
+2K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+2K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+2K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+2K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+2K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+2K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+2K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+2K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+2K053324Chromolite SystemChromogenex Plc200631—
+2K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+2K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+2K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+2K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+2K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+2K051255Lumiphase-ROpusmed, Inc.2005143—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+2K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+3K203054FlexSysGme German Medical Engineering GmbH20210—
+3K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191693BC-5Reveallux, Corp20190—
+3K183708Poly ClearMedtek Skincare, LLC201922—
+3K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+3K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+3K160880Photonica ProfessionalWard Photonics, LLC20166—
+3K153229SuperbiumBios S.R.L.20162—
+3K153717Venus Versa SystemVenus Concept, Ltd.20161—
+3K153081Clear Bi-LightMichael Todd, LP201646—
+3K152790Venus Versa SystemVenus Concept, Ltd.20160—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K140386Lumina 24Rogers Sciences, Inc.20150—
+3K141237Harmony LiteAlma, Inc.20154—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+3K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—