FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Wireless Earlens Light Driven Hearing Aid
K Number: K153634
·
Decision Apr 6, 2016
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
3
Review Days
110
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Basic Information
- Device Name
- Wireless Earlens Light Driven Hearing Aid
- K Number
- K153634
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3315
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Earlens Corporation
- Date Received
- December 18, 2015
- Decision Date
- April 6, 2016
- Product Code
- PLK
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLK | Tympanic Membrane Direct Contact Hearing Aid | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLK), ordered by most recent decision date.
Earlens Contact Hearing Aid
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EarLens Contact Hearing Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat