# K260413: Levo Gen 2 Tinnitus Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Levo Medical Corporation
- Decided: Aug 13, 2026 after 185 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K221125 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221125: SilentCloud, Aureliym GmbH (2023) Summary page 5.

## Indications for use
The Levo Gen2 is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Source page: https://510kreport.com/device/K260413
Methodology: https://510kreport.com/methodology