510(k) Report

Devices descending from K980361

178 later devices reach Dermablate ER: Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+1K014057Dermastar ER:Yag Laser SystemAsclepion-Meditec AG200218—
+2K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+2K083253Lotus II Pulsed ER: Yag Laser SystemLaseroptek Co., Ltd.20091—
+2K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+2K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+2K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC200313—
+2K030181International Biophysics Corporation (Ibc) Laser Peel SystemInternational Biophysics Corp.20030—
+2K021946Cell Robotics Ultra-Light Peel Laser SystemCell Robotics, Inc.20020—
+3K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+3K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+3K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+3K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K173285Joule SystemSciton, Inc20185—
+4K153229SuperbiumBios S.R.L.20162—
+4K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233143PiXel8-RevealRohrer Aesthetics20240—
+5K230077LaserMENeauvia North America20232—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K180508Joule SystemSciton, Inc20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+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
+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—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+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—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+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—