Levo Gen 2 Tinnitus Therapy System— 510(k) K260413

Name: FDA 510(k) clearance K260413
Creator: U.S. Food and Drug Administration
Published: 2026-08-13

Substantially Equivalent

Levo Medical Corporation

FDA 510(k) clearance K260413 for Levo Gen 2 Tinnitus Therapy System, Substantially Equivalent on 2026-08-13. Applicant: Levo Medical Corporation. Device class: 2.

Clearance details

Applicant: Levo Medical Corporation
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2026-02-09
Decision date: 2026-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, Bc, CA

Download summary PDF View on FDA.gov ↗

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