510(k) K260413 ยท KLW Masker, Tinnitus
Levo Gen 2 Tinnitus Therapy System
| Applicant | Levo Medical Corporation, Victoria, Bc, CA |
| Decision | Substantially Equivalent, Aug 13, 2026 |
| Received | Feb 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260413
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.