510(k) Report

Devices descending from K024093

756 later devices reach Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+1K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+1K033946Lovely SystemMsq (M2), Ltd.2004737—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+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—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K141237Harmony LiteAlma, Inc.20154—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063249BeamaxMedic Sharplight, Ltd.200758—
+2K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+2K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+2K053324Chromolite SystemChromogenex Plc200631—
+2K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K200616E>EyeCE-Swin20200—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K180508Joule SystemSciton, Inc20183—
+3K173285Joule SystemSciton, Inc20185—
+3K172413MT ONEM&T S.R.L.20175—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K153717Venus Versa SystemVenus Concept, Ltd.20161—
+3K152790Venus Versa SystemVenus Concept, Ltd.20160—
+3K152714Quanta ForteQuanta System Spa201513—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K090724OR-LightYperion Technology20090—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—