K253355
- 510(k) number
- K253355
- Device name
- Difiney Advanced Anti Snoring Device 4.0
- Applicant
- Fissiontech, LLC NY · US
- Product code
- LRK — Device, Anti-Snoring
- Decision date
- 2025-10-29
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253355.pdf
Official FDA record: K253355
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.