K231749
- 510(k) number
- K231749
- Device name
- Radio Frequency System
- Applicant
- Shenzhenshi Sincoheren S&T Development Co., Ltd. CN
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2023-10-19
- Date received
- 2023-06-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K231749.pdf
Official FDA record: K231749
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.