510(k) Report

Devices descending from K030527

856 later devices reach Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090399Trios SystemViora, Ltd.20090—
+1K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+1K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+1K033946Lovely SystemMsq (M2), Ltd.2004737—
+1K033933Powerlite 600 EX SystemPreswede AB20040—
+1K032460Profile BBL SystemSciton, Inc2003569—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+2K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+2K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+2K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+2K081578Accela SystemGenesis Biosystems, Inc.20080—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063249BeamaxMedic Sharplight, Ltd.200758—
+2K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K053324Chromolite SystemChromogenex Plc200631—
+2K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+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—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K141237Harmony LiteAlma, Inc.20154—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+3K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251632Optimas MAX SystemInMode, Ltd.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—
+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—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—