510(k) clearance
FAQ™ (FAQ 411)
- 510(k) number
- K261565
- Applicant
- Foreo, Inc.
- Decision date
- Oct 22, 2026
- Date received
- May 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NFO
- Device type
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device class
- Class II
- Regulation
- 21 CFR 882.5890
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Las Vegas, NV, US