K252531 is an FDA 510(k) clearance for the Myosa (S1H, S1, S2, S3, S1M, S2M). This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Myofunctional Research Co. (Helnsvale, AU). The FDA issued a Cleared decision on March 2, 2026, 202 days after receiving the submission on August 12, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K252531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2025 |
| Decision Date | March 02, 2026 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK — Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |