Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013532963

FEI Number

3013532963

Entity Name

Fabris Lane Eyewear (Wenzhou) LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

177 Yaohua Road, 3rd Floor, Louqiao, Ouhai District,, Wenzhou Zhejiang 32500, CN

Establishment Type(s)

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

Crizal Sun Varilux Sharpview Ovation Optifog Xperio Trivex TruClear Definity Crizal Small Fit Essilor Ideal Avance My Vision Check Online Vision Test 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 Essilor Luxottica Essilor Luxottica

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2006-12-01
QTO	Digital Visual Acuity Test	Ophthalmic	Class 1	886.1150	2022-09-26
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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1977-12-19
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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
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

Similar Registrations

Registration Number	Establishment Name	Location
3013956081	RENEE'S READERS	New City, NY, US
3026270768	ASIASTAR INDUSTRY(HUIZHOU)CO., LTD	Huizhou City Guangdong, CN
3000180670	Dongguan Rijinyuehui Optical Co.,Ltd	Dongguan Guangdong, CN
3009206998	WORLDWIDE PACKAGING, INC	Livermore, CA, US
3013009176	HYUNDAI SAFETYWEAR CO.	Tainan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013532963. Last updated year: 2026. Please use registration number 3013532963 when referencing this establishment in official correspondence.