K222958
- 510(k) number
- K222958
- Device name
- mJOULE RF System and Accessories
- Applicant
- Sciton, Inc CA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-04-23
- Date received
- 2022-09-27
- 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: K222958.pdf
Official FDA record: K222958
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.