Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)— 510(k) K252531

Substantially Equivalent

Myofunctional Research Co.

FDA 510(k) clearance K252531 for Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2), Substantially Equivalent on 2026-03-02. Applicant: Myofunctional Research Co..

Clearance details

Applicant: Myofunctional Research Co.
Product code: Code LRK
Advisory panel: Dental
Date received: 2025-08-12
Decision date: 2026-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helnsvale, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.