Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038269608

FEI Number

3038269608

Entity Name

Essilor Laboratories of America, Inc. dba Omega Northcreek Lab

City/State/Country

Dallas, TX, US

Establishment Address

13675 N Stemmons Fwy, Dallas, TX 75234, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Essilor of America, Inc (Owner Number: 8010073)

Owner / Operator Contact Address

13515 N Stemmons Fwy, Dallas, TX 75234, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN250016

PMA Number

N/A

All Registered Proprietary Names

Presio i Approval Essilor Stellest, Essilor Stellest Glasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2009-04-30
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
1624788	ESSILOR OF AMERICA, INC.	DALLAS, TX, US
3010910479	ESSILOR TIJUANA OPTICA, S. DE R.L. DE C.V.	CHIHUAHUA, MX
3004110262	ESSILOR INTERNATIONAL, S.A.	LIGNY EN BARROIS Meuse, FR
3008853323	Essilor Canada	Etobicoke Ontario, CA

Similar Registrations

Registration Number	Establishment Name	Location
3012433574	Essilor Tijuana Optica	Tijuana Baja California, MX
8043274	JIANN LIH OPTICAL CO., LTD.	TAINAN City, TW
3012981754	WEIFANG GOERTEK ELECTRONICS CO., LTD.	WEIFANG Shandong, CN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
3012414867	Taizhou Jiahong Glasses Co.,Ltd	Taizhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038269608. Last updated year: 2026. Please use registration number 3038269608 when referencing this establishment in official correspondence.