510(k) Report

Devices descending from K033549

679 later devices reach Starlux Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+1K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+1K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+1K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+1K050950Models Crystal 512, Record 618, Optima 518 Photo Epilation SystemsActive Optical Systems, Ltd./Efraim Bidas20050—
+1K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+1K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+1K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+1K041969Aurora DSSyneron Medical, Ltd.2004302—
+1K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+2K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+2K233473Deka LotusEl.En S.P.A.20241—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K173285Joule SystemSciton, Inc20185—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K141237Harmony LiteAlma, Inc.20154—
+2K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+2K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+2K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+2K130459Tria Fan SystemTria Beauty, Inc.20131—
+2K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+2K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K080638CLAROClrs Technology Corporation20082—
+2K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+2K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+2K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+2K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+2K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+2K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+2K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+2K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+2K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+2K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+2K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+2K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+2K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+2K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+2K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K250281Deka LotusEl.En S.P.A.20250—
+3K241270BTL-754BTL Industries, Inc.20251—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K234057NirvanaEl.En S.P.A.20240—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K230077LaserMENeauvia North America20232—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K202172StarWalkerFotona D.O.O.20203—
+3K200616E>EyeCE-Swin20200—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193426Elite iQCynosure, LLC20201—
+3K180508Joule SystemSciton, Inc20183—
+3K172413MT ONEM&T S.R.L.20175—
+3K171227StarWalkerFotona D.O.O.20177—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+3K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+3K152714Quanta ForteQuanta System Spa201513—
+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—