510(k) Report

Devices descending from K201594

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241656Eneka SelectifTermosalud20241—
+2K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—