K253683
- 510(k) number
- K253683
- Device name
- FAQ (LED Panel); FAQ (Dual LED Panel)
- Applicant
- Foreo, Inc. NV · US
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2026-02-20
- Date received
- 2025-11-21
- 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: K253683
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.