510(k) Report

Devices descending from K191321

8 later devices reach Primelase Excellence through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+1K223680Eneka ProTermosalud20230—
+1K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+1K193367elysion-proHigh Technology Products S.L.U20203—
+2K241656Eneka SelectifTermosalud20241—
+2K222369PURE LaserEndymed Medical, Ltd.20220—
+2K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+3K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—