K231216
- 510(k) number
- K231216
- Device name
- POTENZA
- Applicant
- Jeisys Medical, Inc. KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-12-10
- Date received
- 2023-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K231216.pdf
Official FDA record: K231216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.