# K231749: Radio Frequency System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhenshi Sincoheren S&T Development Co., Ltd.
- Decided: Oct 19, 2023 after 126 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: 11 generations back to K943450 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121481: Infini Radiofrequency System, Lutronic Corporation (2013) Summary page 4.

## Indications for use
The Radio Frequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K231749
Methodology: https://510kreport.com/methodology