Wireless Earlens Light Driven Hearing Aid— 510(k) K153634

Name: FDA 510(k) clearance K153634
Creator: U.S. Food and Drug Administration
Published: 2016-04-06

Substantially Equivalent

Earlens Corporation

FDA 510(k) clearance K153634 for Wireless Earlens Light Driven Hearing Aid, Substantially Equivalent on 2016-04-06. Applicant: Earlens Corporation. Device class: 2.

Clearance details

Applicant: Earlens Corporation
Product code: Code PLK
Device class: Class 2
Regulation: 21 CFR 874.3315
Advisory panel: Ear, Nose, Throat
Date received: 2015-12-18
Decision date: 2016-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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