510(k) Report

Devices descending from K143519

32 later devices reach The MeDioStar NeXT Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+1K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+1K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+1K152714Quanta ForteQuanta System Spa201513—
+2K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+2K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+2K234057NirvanaEl.En S.P.A.20240—
+2K232236EchoQuanta System Spa20230—
+2K221571InMode Multi-systemInMode, Ltd.20222—
+2K192856MT OneM&T S.R.L.20202—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K191942MT One DiamondM&T S.R.L.20191—
+2K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+2K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+2K172413MT ONEM&T S.R.L.20175—
+3K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+3K251632Optimas MAX SystemInMode, Ltd.20251—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K223680Eneka ProTermosalud20230—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+3K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+3K200736Stardust MedI.T.S. Group S.R.L.20200—
+3K200616E>EyeCE-Swin20200—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+4K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+4K241656Eneka SelectifTermosalud20241—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—