Cleared Traditional

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)

K252531 · Myofunctional Research Co. · Dental
Mar 2026
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K252531 is an FDA 510(k) clearance for the Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2), 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 review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K252531 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LRK — Device, Anti-snoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5570