Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026654653

FEI Number

3026654653

Entity Name

GOERTEK OPTICAL TECHNOLOGY CO., LTD.

City/State/Country

Weifang Shandong, CN

Establishment Address

Building 1, Goer Phase III Optoelectronic Industrial Park, No.3999, Huixian Road, Yongchun Community,, Qingchi Sub-district Office, High-Tech Development Zone, Weifang Shandong 261061, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Goertek Optical Technology Co., Ltd. (Owner Number: 10093762)

Owner / Operator Contact Address

Building 1, Goer Phase III Optoelectronic Industrial Park, No.3999, Huixian Road, Yongchun Community,, Qingchi Sub-district Office, High-Tech Development Zone, Weifang, CN-SD 261061, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2025-07-03
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2025-07-03
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-07-03

Official Correspondent

Joanna Zou

US Agent Details

Richard Shea Email: richard.shea@goertekusa.com Phone: (425) 7866685

Related Public Records

Same Entity

Goertek Optical Technology Co., Ltd.

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

View Entity Profile →

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

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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 3026654653. Last updated year: 2026. Please use registration number 3026654653 when referencing this establishment in official correspondence.