Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617804

FEI Number

3001556165

Entity Name

LUXOTTICA TRISTAR (DONG GUAN) OPTICAL CO., LTD.

City/State/Country

DONG GUAN CITY Guangdong, CN

Establishment Address

OU DENG ZONE, GAO BU TOWN, DONG GUAN CITY Guangdong --, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LUXOTTICA (Owner Number: 9069303)

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

Luxottica Oakley Inc Tory Burch Ferragamo Revo Burberry Ralph Lauren Michael Kors DKNY Chanel Tiffany Prada RayBan Vogue Dolce and Gabanna Bulgari Miu Miu Arnette Brooks Brothers Armani Persol Polo Versace Donna Karen Swarovski Miraflex Nuance Audio

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	2012-04-11
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-08-17
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1998-03-12
SCR	Air-Conduction Hearing Aid Software	Ear, Nose, Throat	Class 2	874.3335	2025-02-06

Official Correspondent

Francesco Iavarone

US Agent Details

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

Related Public Records

Same Entity

LUXOTTICA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681249	FUKUI MEGANE INDUSTRY CO., LTD.	SABAE Fukui, 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 9617804. Last updated year: 2026. Please use registration number 9617804 when referencing this establishment in official correspondence.