# K232301: Define RF Microneedling System

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic Management Partners
- Decided: Mar 14, 2024 after 226 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: 14 generations back to K943450 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160469: AGNES, Gowoonsesang Cosmetics Co., Ltd. (2017) Summary page 4.
- K192728: Agnes, Agnes Medical Co., Ltd. (2019) Summary page 5.

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

Source page: https://510kreport.com/device/K232301
Methodology: https://510kreport.com/methodology