# K160469: AGNES

- Pathway: 510(k) (Traditional)
- Applicant: Gowoonsesang Cosmetics Co., Ltd.
- Decided: Jan 5, 2017 after 321 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 26 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881276: HR-5000 Electrosurgical Device for New Indications, Ime Co., Ltd. (1988) Summary page 4.
- K153727: INTRAcel Premium Fractional RF Micro Needle (FRM) System, Jeisys Medical, Inc. (2016). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K192728: Agnes (2019), 6 descendants of its own
- K203013: AGNES (2022), 4 descendants of its own
- K223805: Agnes (2023), 3 descendants of its own
- K242469: RFMagik Lite (2025), 2 descendants of its own
- K241832: Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (2025), 1 descendant of its own

## Indications for use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K160469
Methodology: https://510kreport.com/methodology