510(k) Report

Devices descending from K180719

13 later devices reach InMode Diolaze System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+1K221571InMode Multi-systemInMode, Ltd.20222—
+1K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+2K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+2K251632Optimas MAX SystemInMode, Ltd.20251—
+2K223680Eneka ProTermosalud20230—
+2K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+2K193367elysion-proHigh Technology Products S.L.U20203—
+3K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+3K241656Eneka SelectifTermosalud20241—
+3K222369PURE LaserEndymed Medical, Ltd.20220—
+3K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—