EARLENS CORPORATION

FDA Device Registration & Listing · Menlo Park, CA, US · Registration 3010863048

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010863048
FEI Number
3010863048
Entity Name
EARLENS CORPORATION
City/State/Country
Menlo Park, CA, US
Establishment Address
1165 O'Brien Dr, Menlo Park, CA 94025, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Earlens Corporation (Owner Number: 10050793)
Owner / Operator Contact Address
1165 O'Brien Dr, Menlo Park, CA 94025, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182480
PMA Number
N/A

All Registered Proprietary Names

Earlens Contact Hearing Solution, Tympanic Lens, Ear Tip, Processor, Charger, Earlens Fitting Software

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PLK Tympanic Membrane Direct Contact Hearing Aid Ear, Nose, Throat Class 2 874.3315 2019-03-27

Official Correspondent

Simin Shamsfallah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Earlens Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010863048. Last updated year: 2026. Please use registration number 3010863048 when referencing this establishment in official correspondence.
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