510(k) Report

Devices descending from K223738

2 later devices reach Alpha Control Liner System (ACLS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl20251—
+2K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl20260—