510(k) clearance
AesyBite Active
- 510(k) number
- K260360
- Applicant
- Aesyra SA
- Decision date
- Oct 30, 2026
- Date received
- Feb 4, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HCC
- Device type
- Device, Biofeedback
- Device class
- Class II
- Regulation
- 21 CFR 882.5050
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Lausanne, CH