510(k) Report

Devices descending from K171094

6 later devices reach Thermi Reusable Non-invasive RF Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+1K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+2K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+2K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+2K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+3K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—