K252525
- 510(k) number
- K252525
- Device name
- AIO Breathe
- Applicant
- Aiomega, LLC TX · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-11-06
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K252525.pdf
Official FDA record: K252525
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.