Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616387

FEI Number

3005795544

Entity Name

PREMIER OPTICAL MFY. LTD.

City/State/Country

KOWLOON BAY, HK

Establishment Address

9/F., ROOM B13, BLOCK B,, TONIC INDUSTRIAL CENTRE,19 LAM HING ST., KOWLOON BAY 000, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PREMIER OPTICAL MFY. LTD. (Owner Number: 9039778)

Owner / Operator Contact Address

9/F., ROOM B13, BLOCK B, TONIC, INDUSTRIAL CENTRE, 19 LAM HING, STREET, KOWLOON BAY, HK-NOTA --, HK

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
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2018-08-21
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2002-05-09
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2002-05-09

Official Correspondent

RILMOND WONG

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

PREMIER OPTICAL MFY. 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
3003837870	Huixiang Optical Company Limited	Yujiang Jiangxi, CN

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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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 9616387. Last updated year: 2026. Please use registration number 9616387 when referencing this establishment in official correspondence.