510(k) Report

Devices descending from K042319

284 later devices reach Reliant Laser II System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, 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—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+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—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+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—
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221671CellFX® SystemPulse Biosciences, Inc.20220—
+6K210084SilkroHironic Co., Ltd.20223—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+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—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K200616E>EyeCE-Swin20200—
+6K200786Venus EpileveVenus Concept USA, Inc.20200—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180406Ellipse YdunEllipse A/S20180—
+6K171227StarWalkerFotona D.O.O.20177—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152714Quanta ForteQuanta System Spa201513—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K233123SilkroHironic Co., Ltd.20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K233143PiXel8-RevealRohrer Aesthetics20240—