FDA Product Code
FDA Product Code PLK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3315
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182480 | Earlens Contact Hearing Aid | Earlens Corporation | 2019-01-25 | Traditional | PDF ↗ |
| K153634 | Wireless Earlens Light Driven Hearing Aid | Earlens Corporation | 2016-04-06 | Traditional | PDF ↗ |
| DEN150002 | EarLens Contact Hearing Device | Earlens Corporation | 2015-09-29 | Direct | — |
Product code PLK · Class II · Ear, Nose, Throat. Data: openFDA.