Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005674463

FEI Number

3005674463

Entity Name

BBGR

City/State/Country

SEZANNE Marne, FR

Establishment Address

67 RUE HAUTE, SEZANNE Marne 51120, FR

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Presio i Approval Small Fit Ovation Varilux Xperio Trivex Presio i Approval Kodak Avance TruClear DEFINITY 2 Definity VARILUX-2 Crizal Sharpview Essilor Ideal Optifog

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
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2006-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

M Shannon McMurrey Business: EssilorLuxottica Email: smcmurrey@essilorusa.com Phone: (972) 8005206

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
3038269608	Essilor Laboratories of America, Inc. dba Omega Northcreek Lab	Dallas, TX, US

Similar Registrations

Registration Number	Establishment Name	Location
3012433574	Essilor Tijuana Optica	Tijuana Baja California, MX
8043274	JIANN LIH OPTICAL CO., LTD.	TAINAN City, TW
3038269608	Essilor Laboratories of America, Inc. dba Omega Northcreek Lab	Dallas, TX, US
3012981754	WEIFANG GOERTEK ELECTRONICS CO., LTD.	WEIFANG Shandong, CN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005674463. Last updated year: 2026. Please use registration number 3005674463 when referencing this establishment in official correspondence.