Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681547

FEI Number

1000304358

Entity Name

FGX EUROPE Ltd

City/State/Country

London London, City of, GB

Establishment Address

50 Broadway, Suite 1, 7th Floor, London London, City of SW1H OBL, GB

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on 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

Essilor Luxottica

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1978-01-27

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
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

Registration Number	Establishment Name	Location
3007009595	RAEN OPTICS	Oceanside, CA, US
3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681547. Last updated year: 2026. Please use registration number 9681547 when referencing this establishment in official correspondence.