# Agnes Medical Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 7 (2019–2025): 7 510(k) clearances
- Product codes: GEI (7)
- 510(k) review time since 2016: median 248 days, against 113 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ShenB Co., Ltd.: 1 (https://510kreport.com/company/shenb)
- Jeisys Medical, Inc.: 1 (https://510kreport.com/company/jeisys-medical)
- Gowoonsesang Cosmetics Co., Ltd.: 1 (https://510kreport.com/company/gowoonsesang-cosmetics)

## Firms that cite its devices most
- Aesthetic Management Partners: 1 (https://510kreport.com/company/aesthetic-management-partners)

## Its most-cited devices
- K242469: RFMagik Lite (2025), cited by 2
- K192728: Agnes (2019), cited by 2
- K223805: Agnes (2023), cited by 1
- K203013: AGNES (2022), cited by 1

## Recent decisions
- K250217: AGNES Ultra (Sep 3, 2025)
- K243713: Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (Aug 19, 2025)
- K242469: RFMagik Lite (Apr 25, 2025)
- K230837: PlazMagik (Feb 29, 2024)
- K223805: Agnes (May 4, 2023)
- K203013: AGNES (Jul 14, 2022)
- K192728: Agnes (Oct 24, 2019)

Source page: https://510kreport.com/company/agnes-medical