Levo Gen 2 Tinnitus Therapy System— 510(k) K260413
Substantially EquivalentLevo 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.
Summary
Levo Medical's Levo Gen 2 Tinnitus Therapy System is filed under product code KLW, tinnitus maskers. The record doesn't describe the system beyond its name and that code.
Class II, 21 CFR 874.3400. Ear, Nose, Throat is both the classification panel and the review panel. It was a Traditional 510(k).
Levo filed from Victoria, British Columbia, Canada. The substantially equivalent decision came 185 calendar days after receipt (February 9 to August 13, 2026).
Clearance details
- Applicant
- Levo Medical Corporation
- Product code
- Product code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Victoria, Bc, CA
Recent devices under product code KLW
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