510(k) Report

Devices descending from K012545

318 later devices reach Aramis Dermatlogic Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K192856MT OneM&T S.R.L.20202—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K180508Joule SystemSciton, Inc20183—
+7K180406Ellipse YdunEllipse A/S20180—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K141237Harmony LiteAlma, Inc.20154—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K130501IntensifEndymed Medical, Ltd.201457—
+7K131758Surgen UPollogen, Ltd.20135—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K230308Alma HarmonyAlma Lasers, Inc.20232—
+8K223680Eneka ProTermosalud20230—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K193201BTL-785FBtl20208—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K193426Elite iQCynosure, LLC20201—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K171227StarWalkerFotona D.O.O.20177—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K152714Quanta ForteQuanta System Spa201513—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K241656Eneka SelectifTermosalud20241—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—