510(k) Report

Devices descending from K111851

33 later devices reach Mediostar Next through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+2K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+2K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+2K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+2K152714Quanta ForteQuanta System Spa201513—
+3K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+3K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K232236EchoQuanta System Spa20230—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K192856MT OneM&T S.R.L.20202—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191942MT One DiamondM&T S.R.L.20191—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K172413MT ONEM&T S.R.L.20175—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K223680Eneka ProTermosalud20230—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200736Stardust MedI.T.S. Group S.R.L.20200—
+4K200616E>EyeCE-Swin20200—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K241656Eneka SelectifTermosalud20241—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—