K242227
- 510(k) number
- K242227
- Device name
- GENEO X ELITE
- Applicant
- Pollogen, Ltd. IL
- Product code
- PAY — Over-The-Counter Radiofrequency Coagulation Device F
- Decision date
- 2025-10-12
- Date received
- 2024-07-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K242227.pdf
Official FDA record: K242227
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.