K-number	K153634
Device name	Wireless Earlens Light Driven Hearing Aid
Applicant	Earlens Corporation
Product code	PLK
Device class	Class II
Decision date	Apr 6, 2016
Decision	Substantially Equivalent
Regulation	874.3315

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Source

View the full FDA submission: accessdata.fda.gov

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Wireless Earlens Light Driven Hearing Aid

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