Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011164728

FEI Number

3011164728

Entity Name

WELL SUN OPTICAL TECHNOLOGY LIMITED.

City/State/Country

Tainan, TW

Establishment Address

No.38, sec.2, Zong-an St. Annan District, Tainan 709, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WELL SUN OPTICAL TECHNOLOGY LIMITED. (Owner Number: 10053439)

Owner / Operator Contact Address

No.38, sec.2, Zong-an St. Annan District, Tainan, TW-TNN 709, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

reading glasses Frame Shield, eye, ophthalmic frame Sponge, ophthalmic Sunglasses Spectacle, magnifying

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2025-12-02
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-12-02
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2016-12-05
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2025-12-02
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2016-12-05
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2016-12-05
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2016-12-05

Official Correspondent

WILLIAM HOU

US Agent Details

Shane Heist Email: shane@sunheist.com Phone: (225) 2470033

Related Public Records

Same Entity

WELL SUN OPTICAL TECHNOLOGY LIMITED.

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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
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

Similar Registrations

Registration Number	Establishment Name	Location
3012433574	Essilor Tijuana Optica	Tijuana Baja California, MX
8043274	JIANN LIH OPTICAL CO., LTD.	TAINAN City, TW
3038269608	Essilor Laboratories of America, Inc. dba Omega Northcreek Lab	Dallas, TX, US
3012981754	WEIFANG GOERTEK ELECTRONICS CO., LTD.	WEIFANG Shandong, CN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011164728. Last updated year: 2026. Please use registration number 3011164728 when referencing this establishment in official correspondence.