510(k) Report

Devices descending from K881276

10 later devices reach HR-5000 Electrosurgical Device for New Indications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+2K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+2K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+2K192728AgnesAgnes Medical Co., Ltd.20196—
+3K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+3K203013AGNESAgnes Medical Co., Ltd.20224—
+4K223805AgnesAgnes Medical Co., Ltd.20233—
+5K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+6K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+6K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—