510(k) Report

Devices descending from K964760

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K200693K2 MobileHulaser, Inc.20202—
+6K202172StarWalkerFotona D.O.O.20203—
+6K192621Medical RFTriworks Group Srl20200—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K200616E>EyeCE-Swin20200—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K183156V-LaserWontech Co., Ltd.20193—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180508Joule SystemSciton, Inc20183—
+6K180423Empower H65Quanta System Spa20181—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K171702Exciplex308nmClarteis20175—
+6K172413MT ONEM&T S.R.L.20175—
+6K163449HyPHo Laser SystemHyper Photonics Srl20170—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K163197Cook Holmium Laser FiberCook Incorporated20170—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+6K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+6K170331Cyber HoQuanta System Spa20179—
+6K163009LithoQuanta System Spa201612—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+6K152714Quanta ForteQuanta System Spa201513—
+6K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K133405MinnieElettronica Valseriana Srl20140—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131839DC 7Dc International, LLC20130—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K132431Thermage CPT SystemSolta Medical, Inc.2013171
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+6K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+6K111026ApolloPollogen, Ltd.201114—
+6K111784Venus Swan SystemVenus Concept, Ltd.20111—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K110685Flexiva TractipBoston Scientific Corp20112—
+6K110686AccutracBoston Scientific Corp20110—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+6K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+6K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—