510(k) Report

Devices descending from K003886

371 later devices reach Palomar Spalight Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+1K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+2K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+2K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+2K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+2K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+2K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+2K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K080638CLAROClrs Technology Corporation20082—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+2K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+2K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+2K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+2K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+2K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K233473Deka LotusEl.En S.P.A.20241—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K171227StarWalkerFotona D.O.O.20177—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K152012EVO platformQuanta System Spa201537—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+3K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+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—
+3K090744CLAROClrs Technology Corporation20101—
+3K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083730IsolazAesthera Corporation20093—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+3K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250281Deka LotusEl.En S.P.A.20250—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K241270BTL-754BTL Industries, Inc.20251—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230077LaserMENeauvia North America20232—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K200616E>EyeCE-Swin20200—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193426Elite iQCynosure, LLC20201—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K180508Joule SystemSciton, Inc20183—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K172413MT ONEM&T S.R.L.20175—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—