K253868
- 510(k) number
- K253868
- Device name
- QuietLab Pro
- Applicant
- QuietLab, LLC NY · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-12-05
- Date received
- 2025-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253868.pdf
Official FDA record: K253868
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.