510(k) Report

Devices descending from K943584

251 later devices reach Presterilized Endodontic Files through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+9K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K230308Alma HarmonyAlma Lasers, Inc.20232—
+9K223680Eneka ProTermosalud20230—
+9K222701MANTA LaserSqualus Med, Ltd.20222—
+9K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+9K222369PURE LaserEndymed Medical, Ltd.20220—
+9K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+9K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+9K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+9K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+9K210847UltraClear Fractional Laser SystemFa International, LP20210—
+9K203728DarwinLuvo Medical Technologies, Inc.20211—
+9K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+9K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+9K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+9K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+9K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+9K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+9K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+9K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+9K171227StarWalkerFotona D.O.O.20177—
+9K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+9K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+9K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+9K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+9K152714Quanta ForteQuanta System Spa201513—
+9K140120EPIC 10Biolase, Inc.20141—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+9K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+9K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+9K121327Diolase 10SBiolase Technology, Inc.20132—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+9K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+9K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+9K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+10K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+10K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+10K252561BTL-754FFBTL Industries, Inc.20260—
+10K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+10K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+10K242859VEGAIbramed Equipamentos Médicos20250—
+10K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+10K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+10K241656Eneka SelectifTermosalud20241—
+10K241600DermablateAsclepion Laser Technologies GmbH20240—
+10K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+10K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+10K234057NirvanaEl.En S.P.A.20240—
+10K233024Alma HarmonyAlma Lasers, Inc.20241—
+10K232236EchoQuanta System Spa20230—
+10K231054V-LaserWontech Co., Ltd.20231—
+10K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+10K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+10K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+10K223540AvalancheLase FamilyFotona D.O.O.20230—
+10K213267Dynamis Pro FamilyFotona D.O.O.20222—
+10K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+10K221571InMode Multi-systemInMode, Ltd.20222—
+10K213350mJOULE System and AccessoriesSciton, Inc20220—
+10K202288FinebeamSNJ Co., Ltd.20212—
+10K212607DarwinLuvo Medical Technologies, Inc.20210—
+10K203788DermaV Laser SystemLutronic Corporation202101
+10K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+10K202172StarWalkerFotona D.O.O.20203—
+10K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+10K192856MT OneM&T S.R.L.20202—
+10K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+10K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+10K191942MT One DiamondM&T S.R.L.20191—
+10K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+10K183156V-LaserWontech Co., Ltd.20193—
+10K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+10K181518Sebacia MicroparticlesSebacia, Inc.20180—
+10K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+10K172413MT ONEM&T S.R.L.20175—
+10K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+10K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+10K161185LUCERNA Dental LaserViax Dental Lab20160—
+10K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+10K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+10K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+10K131839DC 7Dc International, LLC20130—
+10K130465EPIC 10SBiolase Technology, Inc.20130—
+10K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+10K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+10K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+11K252723Dynamis Pro FamilyFotona D.O.O.20260—
+11K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+11K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—