510(k) Report

Devices descending from K083207

96 later devices reach Ultrawave Iii EX 1320 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+1K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+1K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+2K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+2K193367elysion-proHigh Technology Products S.L.U20203—
+2K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+2K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+2K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+2K152012EVO platformQuanta System Spa201537—
+2K141237Harmony LiteAlma, Inc.20154—
+2K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+2K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K223680Eneka ProTermosalud20230—
+3K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+3K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+3K222369PURE LaserEndymed Medical, Ltd.20220—
+3K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+3K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+3K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+3K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+3K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+3K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K160368EVO platformQuanta System Spa201636—
+3K152714Quanta ForteQuanta System Spa201513—
+4K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+4K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+4K242859VEGAIbramed Equipamentos Médicos20250—
+4K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+4K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+4K241656Eneka SelectifTermosalud20241—
+4K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+4K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K232236EchoQuanta System Spa20230—
+4K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+4K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+4K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K192856MT OneM&T S.R.L.20202—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172413MT ONEM&T S.R.L.20175—
+4K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+4K163222Discovery Pico FamilyQuanta System Spa201630—
+5K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+5K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200616E>EyeCE-Swin20200—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K213889PicoStarAsclepion Laser Technologies GmbH20220—
+7K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202503ChromeQuanta System Spa202012—
+9K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+9K253765Vanish ProDdc Technologies, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241527Pastelle ProWontech Co., Ltd.20253—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+9K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+9K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+10K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+10K250165PastelleWontech Co., Ltd.20250—