510(k) Report

Devices descending from K960475

403 later devices reach Modified Luxar LX-20 Family CO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K132754Neogen PSR SystemEnergist, Ltd.20132—
+6K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K223727LavieenWontech Co., Ltd.20234—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K223680Eneka ProTermosalud20230—
+7K221873NeoGen PSR SystemEnergist Limited20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K210084SilkroHironic Co., Ltd.20223—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+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—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+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—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K171227StarWalkerFotona D.O.O.20177—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152714Quanta ForteQuanta System Spa201513—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K233123SilkroHironic Co., Ltd.20241—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—