Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006532764

FEI Number

3006532764

Entity Name

ZHANGZHOU AGILTON OPTICAL CO., LTD.

City/State/Country

ZHANGZHOU Fujian, CN

Establishment Address

NO.8 Qianzhai Road, Jiaomei Town, Zhangzhou Taiwanese Investment Zone,, ZHANGZHOU Fujian 363107, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUNCUTE INDUSTRIES CO. LTD. (Owner Number: 9001865)

Owner / Operator Contact Address

No.270 Fuhua Street, Zhongli Dist., Taoyuan City, TW-NOTA 320024, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fleur de Lis Camile Bizien Smith LL BEAN izzo Smith LL BEAN Camile Bizien Fleur de Lis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2007-04-03
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2007-04-03
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2007-04-03
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2007-04-03
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-06-19

Official Correspondent

GARY LIN

US Agent Details

Justine Ho Email: Jho7218@yahoo.com Phone: (214) 4984804

Related Public Records

Same Entity

SUNCUTE INDUSTRIES CO. LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020623	SUNCUTE INDUSTRIES CO. LTD.	TAOYUAN, TW

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

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 3006532764. Last updated year: 2026. Please use registration number 3006532764 when referencing this establishment in official correspondence.