Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004129978

FEI Number

3004129978

Entity Name

KOOLLOOK INTERNATIONAL, LTD

City/State/Country

Shanghai, CN

Establishment Address

No. 19-20 Fortunepark, Lane 1277 , East Zhuanxing Road, Minhang District, Shanghai 201108, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

KOOLLOOK INTERNATIONAL, LTD (Owner Number: 10027176)

Owner / Operator Contact Address

No. 19-20 Fortunepark, Lane 1277, East Zhuanxing Road, Minhang District, Shanghai, CN-SH 201108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

non-vented goggle vented goggle face shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2008-10-09
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-10
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2008-10-09
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2008-10-09

Official Correspondent

GANG DONG

US Agent Details

DON HUA Business: MARCHE INC Email: hua1866@yahoo.com Phone: (626) 3839200

Related Public Records

Same Entity

KOOLLOOK INTERNATIONAL, 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
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

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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004129978. Last updated year: 2026. Please use registration number 3004129978 when referencing this establishment in official correspondence.