510(k) Report

Devices descending from K964760

908 later devices reach Dornier Medilas Fiber Tome Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+1K982629Dornier Medilas DDornier Surgical Products, Inc.1998698—
+1K981718Dornier Medilas HDornier Surgical Products, Inc.1998348—
+2K181510Echolaser X4El.En Electronic Engineering Spa20183—
+2K094049Stlase Diode LaserDental Photonics, Inc.201023—
+2K073427Medilas D Family LasersDornier Medtech America, Inc.200881—
+2K070536Medilas D Family LasersDornier Medtech America, Inc.2007197—
+2K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+2K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc.2002695—
+2K021724Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc.2002305—
+2K991183Dornier Lasertrode FiberDornier Surgical Products, Inc.19990—
+2K984349Dornier Medilas RDornier19990—
+2K983963Dornier Medila HDornier Medtech America, Inc.1998346—
+3K260632Laser Thermal Therapy KitElesta S.P.A20260—
+3K213594Echolaser X4Elesta S.P.A20221—
+3K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+3K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+3K111689StlaseDental Photonics, Inc.201222—
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K060752Acmi Dur-HL Laser SystemsAcmi Corporation20060—
+3K030186Polris LVSyneron Medical, Ltd.2003680—
+3K984591Dornier Medilas H/2Dornier Surgical Products, Inc.1999344—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+4K163128Epic ProBiolase, Inc.201716—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+4K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090762LEDAQuantel Derma GmbH200946—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+4K031671Polaris WRSyneron Medical, Ltd.2003678—
+4K032023W.O.M. Laser U100PLUSW.O.M. World of Medicine AG20030—
+4K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K192856MT OneM&T S.R.L.20202—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172771Epic Pro 940Biolase, Inc.20171—
+5K171227StarWalkerFotona D.O.O.20177—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+5K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153229SuperbiumBios S.R.L.20162—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K141237Harmony LiteAlma, Inc.20154—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+5K140120EPIC 10Biolase, Inc.20141—