510(k) Report

Devices descending from K070805

150 later devices reach Ultrawave II EX 1320 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+1K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+1K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+1K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K173285Joule SystemSciton, Inc20185—
+2K152012EVO platformQuanta System Spa201537—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K180508Joule SystemSciton, Inc20183—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K160368EVO platformQuanta System Spa201636—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K223680Eneka ProTermosalud20230—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+4K163222Discovery Pico FamilyQuanta System Spa201630—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K241656Eneka SelectifTermosalud20241—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232236EchoQuanta System Spa20230—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K192856MT OneM&T S.R.L.20202—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K172413MT ONEM&T S.R.L.20175—
+5K171227StarWalkerFotona D.O.O.20177—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K22079410PLTentech Co., Ltd.20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—