510(k) Report

Devices descending from K003705

766 later devices reach Xtrac Excimer Laser System, Model AL7000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K193426Elite iQCynosure, LLC20201—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181868SHINY RPL SystemIds, Ltd.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171227StarWalkerFotona D.O.O.20177—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151629Guardian 1000Quanta System Spa20150—
+7K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K150051ExiliteBTL Industries, Inc.20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+7K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+7K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—