510(k) Report

Devices descending from K942622

746 later devices reach Laseaway Q-Switched ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970808Medlite IV Q-Switched, Frequency Doubled, ND:Yag LaserContinuum Biomedical, Inc.1997745—
+2K041011Ultralight II ND:Yag Laser SystemSandstone Medical Technologies, LLC20045—
+2K033946Lovely SystemMsq (M2), Ltd.2004737—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K082407Modification to Ultralight II ND: Yag Laser SystemSandstone Medical Technologies, LLC20093—
+3K083272Skinclear Q-Switched ND:Yag LaserGlobal USA Distribution, LLC20080—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K063249BeamaxMedic Sharplight, Ltd.200758—
+3K053324Chromolite SystemChromogenex Plc200631—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K041969Aurora DSSyneron Medical, Ltd.2004302—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K153229SuperbiumBios S.R.L.20162—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K141237Harmony LiteAlma, Inc.20154—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K081578Accela SystemGenesis Biosystems, Inc.20080—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K200616E>EyeCE-Swin20200—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172413MT ONEM&T S.R.L.20175—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K152714Quanta ForteQuanta System Spa201513—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K102461FractoraInvasix, Ltd.201124—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—