510(k) Report

Devices descending from K040081

415 later devices reach Palomar Luxv Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142860Lumenis M22 SystemLumenis, Ltd.2015381
+1K080638CLAROClrs Technology Corporation20082—
+1K073477Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB20083—
+1K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+1K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+1K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+1K050165Modification to Ifl Professional System, Model C100Cyden Limited200510—
+1K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+1K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+1K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+2K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+2K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+2K153566Magma SystemFormatk Systems, Ltd.20162—
+2K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+2K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+2K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K090744CLAROClrs Technology Corporation20101—
+2K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+2K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+2K090399Trios SystemViora, Ltd.20090—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K083730IsolazAesthera Corporation20093—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+2K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+2K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+2K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+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—
+2K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+2K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K233473Deka LotusEl.En S.P.A.20241—
+3K234057NirvanaEl.En S.P.A.20240—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+3K202172StarWalkerFotona D.O.O.20203—
+3K200616E>EyeCE-Swin20200—
+3K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+3K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+3K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K180508Joule SystemSciton, Inc20183—
+3K173285Joule SystemSciton, Inc20185—
+3K172413MT ONEM&T S.R.L.20175—
+3K171227StarWalkerFotona D.O.O.20177—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K162781Magma SparkFormatk Systems, Ltd.20160—
+3K160821Tria SapphireTria Beauty, Inc.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K152714Quanta ForteQuanta System Spa201513—
+3K152012EVO platformQuanta System Spa201537—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+3K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K101415TheraclearTheravant Corporation20101—
+3K093168Mediflash and EsteflashDermeo20100—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+3K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—