K250353
- 510(k) number
- K250353
- Device name
- Oniris; Oniris Plus
- Applicant
- Oniris FR
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-09-04
- Date received
- 2025-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250353.pdf
Official FDA record: K250353
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.