ESSILOR OF AMERICA, INC.

FDA Device Registration & Listing · DALLAS, TX, US · Registration 1624788

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
1624788
FEI Number
1000058437
Entity Name
ESSILOR OF AMERICA, INC.
City/State/Country
DALLAS, TX, US
Establishment Address
13555 N Stemmons Fwy, DALLAS, TX 75234, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Essilor of America, Inc (Owner Number: 8010073)
Owner / Operator Contact Address
13515 N Stemmons Fwy, Dallas, TX 75234, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
DEN250016
PMA Number
N/A

All Registered Proprietary Names

Essilor Stellest, Essilor Stellest Glasses

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QUR Prescription Spectacle Lenses To Reduce The Progression Of Myopia Ophthalmic Class 2 886.5845 2025-09-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Essilor of America, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012433574 Essilor Tijuana Optica Tijuana Baja California, MX
3010910479 ESSILOR TIJUANA OPTICA, S. DE R.L. DE C.V. CHIHUAHUA, MX
3004110262 ESSILOR INTERNATIONAL, S.A. LIGNY EN BARROIS Meuse, FR
3038269608 Essilor Laboratories of America, Inc. dba Omega Northcreek Lab Dallas, TX, US
3008853323 Essilor Canada Etobicoke Ontario, CA

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Registration Number Establishment Name Location
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3028606342 OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD Guangzhou Guangdong, CN
3038274470 BRAINMATTERZ, INC McKinney, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1624788. Last updated year: 2026. Please use registration number 1624788 when referencing this establishment in official correspondence.
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