510(k) Report

Devices descending from K113502

15 later devices reach Advantage Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141555AdvantageLutronic Corporation201414—
+2K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+3K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K223680Eneka ProTermosalud20230—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+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—