K233766
- 510(k) number
- K233766
- Device name
- Geneo X Elite
- Applicant
- Pollogen, Ltd. IL
- Product code
- PAY — Over-The-Counter Radiofrequency Coagulation Device F
- Decision date
- 2024-05-07
- Date received
- 2023-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233766.pdf
Official FDA record: K233766
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.