# K242469: RFMagik Lite

- Pathway: 510(k) (Traditional)
- Applicant: Agnes Medical Co., Ltd.
- Decided: Apr 25, 2025 after 248 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: 22 generations back to K943450 (1995). 269 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231216: Potenza, Jeisys Medical, Inc. (2024). Cleared while this submission was under review Summary page 5.
- K223805: Agnes, Agnes Medical Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K250217: AGNES Ultra (2025), 0 descendants of its own
- 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) (2025), 0 descendants of its own

## Indications for use
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K242469
Methodology: https://510kreport.com/methodology