K240378
- 510(k) number
- K240378
- Device name
- FAQ 201, FAQ 202
- Applicant
- Foreo, Inc. NV · US
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2024-04-19
- Date received
- 2024-02-07
- 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: K240378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.