510(k) Report

Devices descending from K030805

363 later devices reach Mythos 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052874Soprano Hair Removal Diode LaserMsq (M2), Ltd.2005126—
+1K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+2K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+2K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+2K083848Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd.2009125—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+3K123257Emvera DioluxEmvera Technologies, Inc.20123—
+3K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+4K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141986Elux 810 LaserEquipmed North America, Inc.20150—
+4K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+5K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173285Joule SystemSciton, Inc20185—
+5K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+5K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+5K161981Olive PlusAma Network, Inc.20160—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K140120EPIC 10Biolase, Inc.20141—
+5K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—