KLW
- Product code
- KLW
- Device name
- Masker, Tinnitus
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3400
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 78 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260413 | 2026-08-13 | Levo Medical Corporation | Levo Gen 2 Tinnitus Therapy System | |
| K260614 | 2026-06-10 | Sivantos GmbH | Tinnitus Therapy | FDA |
| K233435 | 2024-02-27 | Pnq Health | Peace N Quiet (0.7.0) |
Official FDA classification page: KLW
Classification and pathway per current FDA publications. Data from openFDA (CC0).