510(k) Report

Devices descending from K011677

758 later devices reach Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133158ND: Yag Laser SystemBeijing Toplaser Technology Co., Ltd.20145—
+1K083203Helios II Q-Switched ND:Yag Laser SystemLaseroptek Co., Ltd.20096—
+1K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070—
+1K063072Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems: 532 and 1064 ND:Yag…Candela Corp.20060—
+1K061850Mini-Yag LaserAmerican Lasers, Inc.20060—
+1K043173Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd.200539—
+1K041011Ultralight II ND:Yag Laser SystemSandstone Medical Technologies, LLC20045—
+1K033946Lovely SystemMsq (M2), Ltd.2004737—
+1K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc.200476—
+1K032667Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow)Focus Medical, LLC20043—
+2K170850Alma QAlma Lasers, Ltd.20172—
+2K163123Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20174—
+2K152856Helios IIILaseroptek Co., Ltd.20165—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K110370Q-ClearLight Age, Inc.201135—
+2K082407Modification to Ultralight II ND: Yag Laser SystemSandstone Medical Technologies, LLC20093—
+2K083272Skinclear Q-Switched ND:Yag LaserGlobal USA Distribution, LLC20080—
+2K081408Ellipse MultiflexEllipse A/S20087—
+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—
+2K053324Chromolite SystemChromogenex Plc200631—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K242943Q Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd.20250—
+3K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K212663Helios IV 785Laseroptek Co., Ltd.20223—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K192856MT OneM&T S.R.L.20202—
+3K193609Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd.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—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K131142Genesis Led WandsGenesis Biosystems, 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—
+3K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+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—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+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—
+4K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+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—
+4K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K200616E>EyeCE-Swin20200—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K141975Waterlase Iplus SBiolase, Inc.20150—