Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012297893

FEI Number

3012297893

Entity Name

Luxottica North Europe Ltd.

City/State/Country

St. Albans, Herts Hertfordshire, GB

Establishment Address

2nd floor, Verulam Point, Station Way, St. Albans, Herts Hertfordshire AL1 5HE, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Luxottica of America (Owner Number: 9032320)

Owner / Operator Contact Address

100 Greenwood Industrial Pkwy, McDonough, GA 30253, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stella McCartney Armani K&L Arnette Oakley Michael Kors Polo Ralph Lauren Donna Karan eyewear Chaps fox Eyewear Ray-Ban Burberry Alain Mikli Tory Burch Bulgari Prada Revo Versus Paul Smith Spectacles Coach Tiffany & Co. DKNY Ralph Lauren Purple Label Disney Reed Krakoff Fox Eyewear Miu Miu Vogue Sferoflex Dolce & Gabbana Versace Eye Safety Systems (ESS) Ralph Lauren Brooks Brothers Oliver Peoples Persol Valentino Rayban

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	1999-08-24
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1999-09-24

Official Correspondent

Francesco Iavarone

US Agent Details

Domenico Bon Business: EssilorLuxottica Email: dbon@oakley.com Phone: (949) 9007458

Related Public Records

Same Entity

Luxottica of America

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614827	LUXOTTICA Group SPA	AGORDO Belluno, IT
9614900	Luxottica Group S.P.A.	Sedico Belluno, IT
3004576402	Mirari Japan Co. Ltd.	Chiba Tokyo, JP

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 3012297893. Last updated year: 2026. Please use registration number 3012297893 when referencing this establishment in official correspondence.