FDA.reportPublic FDA data

510(k) K153634

Device
Wireless Earlens Light Driven Hearing Aid
Applicant
EARLENS CORPORATION
510(k) number
K153634
Product code
PLK  
Decision
Substantially Equivalent (SESE)
Decision date
2016-04-06
Date received
2015-12-18
Regulation
874.3315
Classification name
Tympanic Membrane Direct Contact Hearing Aid
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Deborah Arthur
Address
4045-A Campbell Ave. Menlo Park CA US 94025 94025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PLK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182480Earlens Contact Hearing AidEarlens Corporation2019-01-25
DEN150002EarLens Contact Hearing DeviceEarlens Corporation2015-09-29

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases