K240616
- 510(k) number
- K240616
- Device name
- FAQ (102)
- Applicant
- Foreo, Inc. NV · US
- Product code
- PAY — Over-The-Counter Radiofrequency Coagulation Device F
- Decision date
- 2024-07-15
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240616
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.