510(k) Report

Devices descending from K160469

9 later devices reach AGNES through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+1K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+1K192728AgnesAgnes Medical Co., Ltd.20196—
+2K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+2K203013AGNESAgnes Medical Co., Ltd.20224—
+3K223805AgnesAgnes Medical Co., Ltd.20233—
+4K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+5K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+5K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—