510(k) Report

Devices descending from K964760

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+8K232236EchoQuanta System Spa20230—
+8K231146AliTightAlic Iotech, LLC20230—
+8K230663DensityJeisys Medical, Inc.20232—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+8K221989The OligioWontech Co., Ltd.20222—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+8K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+8K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K193266MIINMedico USA, Inc.20210—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K202041Opera EvoQuanta System Spa20200—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K193486Epic 980Biolase, Inc.20202—
+8K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K192990Litho EvoQuanta System Spa20190—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+8K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K163415SlimShape SystemSyneron Medical, Ltd.201714—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162512truSculptCutera, Inc.20165—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+8K152611V20 systemViora, Ltd.20164—
+8K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+8K143559XP1000 RFBTL Industries, Inc.20157—
+8K150035V10 systemViora, Ltd.201531—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+8K143109XP300BTL Industries, Inc.20150—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K142289PK SpatulaGyrus Acmi, Inc.20141—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+8K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+8K130689Symphony RF GeneratorThermigen, Inc.201311—
+8K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+8K122493GenesisplusCutera, Inc.201318—
+8K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+8K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+8K121678DTADGyrus Acmi, Inc.20122—
+8K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+8K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+8K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+8K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+8K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+8K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+8K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+8K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+8K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+8K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+8K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253504Volnewmer™Classys, Inc.20260—
+9K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+9K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—