FDA records / Microcurrent

Is NuFACE Mini Plus FDA cleared?

Yes — the FDA record names NuFACE Mini Plus.

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.

K201680 · View FDA record

Device name in the FDA record
NuFACE Mini Plus
Applicant
Carole Cole Company
Decision date
2021-02-19
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Evidence
FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.

More about NuFACE Mini Plus