KLW — Masker, Tinnitus Class II
FDA product code KLW covers "Masker, Tinnitus", a Class II medical device regulated under 21 CFR 874.3400. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLW
- Device Class
- Class II
- Regulation Number
- 874.3400
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260614 | sivantos | Tinnitus Therapy | June 10, 2026 |
| K233435 | pnq health | Peace N Quiet (0.7.0) | February 27, 2024 |
| K223694 | duearity | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | June 30, 2023 |
| K221168 | goldenear company | Tinnitogram Signal Generator | February 1, 2023 |
| K221125 | aureliym | SilentCloud | January 4, 2023 |
| K201370 | starkey laboratories | Multiflex Tinnitus Technology | June 19, 2020 |
| K193303 | gn hearing | Tinnitus Sound Generator Module | February 20, 2020 |
| K180495 | gn hearing | Tinnitus Sound Generator Module | November 30, 2018 |
| K181586 | gn hearing | Tinnitus Sound Generator Module | July 13, 2018 |
| K171243 | audiofon usa | audifon Tinnitus-Module | October 19, 2017 |
| K163094 | jiangsu betterlife medical co | TinniLogic Mobile Tinnitus Management Device | May 17, 2017 |
| K161562 | sound options tinnitus treatments | Sound Options Tinnitus Treatment | September 28, 2016 |
| K161331 | turtle beach corporation | HyperSound Tinnitus Module | August 23, 2016 |
| K151558 | neurotherapies reset | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | January 20, 2016 |
| K151719 | kw ear lab | REVE134 | October 9, 2015 |
| K150014 | sanuthera | Serenity | July 27, 2015 |
| K150171 | gn resound | Tinnitus Sound Generator Module | May 14, 2015 |
| K150065 | soundcure | SoundCure Serenade Tinnitus Treatment System | April 13, 2015 |
| K140845 | otoharmonics | LEVO TINNITUS MASKING SOFTWARE DEVICE | July 18, 2014 |
| K132965 | amplisound hearing products and services | SOLACE SOUND GENERATORS | March 25, 2014 |