510(k) Report

Devices descending from K955621

677 later devices reach Sharplan Lasers, Inc Silktouch 2 Flash Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20172—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+5K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+5K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+5K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+5K132975Sphinx JRAllmed Systems, Inc.20141—
+5K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+5K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+5K130420SOLEAConvergent Dental, Inc.201321
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+5K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+5K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+5K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+5K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+5K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+5K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+5K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+5K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+5K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+5K053457Vapormax IITrimedyne, Inc.20051—
+5K014290Entec Plasma WandsArthrocare Corp.2002119—
+5K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K233123SilkroHironic Co., Ltd.20241—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+6K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233147PiXel8-RFRohrer Aesthetics20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K223727LavieenWontech Co., Ltd.20234—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K213674CellFX SystemPulse Biosciences, Inc.20220—
+6K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+6K221761SoleaConvergent Dental, Inc.202201
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221671CellFX® SystemPulse Biosciences, Inc.20220—
+6K211000AcutronIlooda Co,., Ltd.20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K211534RevoLix HTLLisa Laser Products GmbH20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212611CO2 Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202250Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20200—
+6K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+6K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd.20205—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd.20191—