FDA records / Acne light devices
Is FOREO ESPADA FDA cleared?
Yes — the FDA record names FOREO ESPADA.
The model name is matched to the linked record below. Clearance is specific to the device and stated use; it is not a performance ranking.
“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. What clearance means
Follow the FDA record.
K162450 · View FDA record
- Device name in the FDA record
- ESPADA Acne-Clearing Blue Light Pen
- Applicant
- Foreo, Inc.
- Decision date
- 2016-11-30
- Product code
- OLP: Over-The-Counter Powered Light Based Laser For Acne
- Evidence
- FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.