510(k) Report

Devices descending from K161458

11 later devices reach Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242175XOD Diathermia Radiofrequency DeviceXod, Inc.20250—
+1K241107Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba…Indiba S. A. U.20250—
+1K243164INDIBA COMPACT devicesIndiba S. A. U.20240—
+1K230412Symmed Elite AestheticTermosalud20231—
+1K191202Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L.20204—
+1K181893T-PLUSWintecare SA20190—
+2K243716Zionic Pro Max (Radiofrequency)Termosalud S.L.20250—
+2K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+3K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+3K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+4K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—