FDA Registration
Active
🇺🇸 United States
Earlens Contact Hearing Solution, Tympanic Lens, Ear Tip, Processor, Charger, Earlens Fitting Software
Reg #: 3010863048
·
FEI: 3010863048
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EARLENS CORPORATION
- Registration Number
- 3010863048
- FEI Number
- 3010863048
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4045A Campbell Avenue
- City
- Menlo Park
- State
- CA
- ZIP
- 94025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182480
Owner / Operator
- Firm Name
- Earlens Corporation
- Operator Number
- 10050793
- Address
- 4045A Campbell Avenue
- City
- Menlo Park
- State
- CA
- Postal Code
- 94025
- Country
- US
- Correspondent
- Simin Shamsfallah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tympanic Membrane Direct Contact Hearing Aid | PLK | Class 2 | Ear, Nose, Throat | No | 2019-03-27 |
Proprietary Names
Earlens Contact Hearing Solution, Tympanic Lens, Ear Tip, Processor, Charger, Earlens Fitting Software
Establishment Types
Manufacture Medical Device