Clearance Summary
EarLens Contact Hearing Device received FDA 510(k) clearance under submission number DEN150002, sponsored by Earlens Corporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2015-09-29.
- Submission: DEN150002
- Applicant / Sponsor: Earlens Corporation
- Clearance pathway: Direct
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3315
- Decision date: 2015-09-29
Classification & Regulation
This clearance is catalogued under FDA product code PLK and 21 CFR 874.3315, within the Ear, Nose, Throat review panel as a Class II device.