# K250217: AGNES Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Agnes Medical Co., Ltd.
- Decided: Sep 3, 2025 after 222 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: 23 generations back to K943450 (1995). 270 ancestors in all.
No later device cites it as a predicate yet.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242469: RFMagik Lite, Agnes Medical Co., Ltd. (2025). Cleared while this submission was under review Summary page 6.

## Indications for use
AGNES RF (DL) handpiece, AGNES RF (F) handpiece and AGNES RF (B) handpiece of AGNES Ultra are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K250217
Methodology: https://510kreport.com/methodology