Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003325113

FEI Number

3003325113

Entity Name

ESSILOR INTERNATIONAL

City/State/Country

CRETEIL Val-de-Marne, FR

Establishment Address

81 BLD J-B OUDRY, CRETEIL Val-de-Marne 94000, 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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2006-12-01
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1977-12-19
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2009-04-30
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

Similar Registrations

Registration Number	Establishment Name	Location
3006755718	DONGGUAN YUEHENG OPTICAL CO. LTD.	Dongguan Guangdong, CN
3015534032	BOLLE SAFETY INC	Carlsbad, CA, US
3007675955	Carl Zeiss Vision Canada, Inc.	Toronto Ontario, CA
1000428458	GKB OPHTHALMICS LIMITED - UNIT II	North Goa Goa, IN
3038136215	MEIVISION (VIETNAM) CO., LTD	Ho Chi Minh City, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003325113. Last updated year: 2026. Please use registration number 3003325113 when referencing this establishment in official correspondence.