K260413
- 510(k) number
- K260413
- Device name
- Levo Gen 2 Tinnitus Therapy System
- Applicant
- Levo Medical Corporation CA
- Product code
- KLW — Masker, Tinnitus
- Decision date
- 2026-08-13
- Date received
- 2026-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260413.pdf
Official FDA record: K260413
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.