EarLens Contact Hearing Device
FDA 510(k) clearance DEN150002 · decided 2015-09-29
Clearance details
- K-number
- DEN150002
- Device name
- EarLens Contact Hearing Device
- Applicant
- Earlens Corporation
- Decision
- Unknown
- Date received
- 2015-01-02
- Decision date
- 2015-09-29
- Days to decision
- 270 days
- Clearance type
- Direct
- Product code
- PLK
- Device class
- 2
- Regulation number
- 874.3315
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Earlens Contact Hearing Aid (K182480) | Earlens Corporation | 2019-01-25 |
| Wireless Earlens Light Driven Hearing Aid (K153634) | Earlens Corporation | 2016-04-06 |
Recalls involving this device
No recalls on record reference this clearance.