Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011307306

FEI Number

3011307306

Entity Name

Shenzhen Xinrun Optical Company Limited

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 222, 2nd Floor, Building 110, Liantang High-tech First Industrial Park, No. 72, Guowei Road, Xianhu Community, Liantang Sub-district, Luohu District, Shenzhen Guangdong 518004, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Xinrun Optical Company Limited (Owner Number: 10047806)

Owner / Operator Contact Address

Room 222, 2nd Floor, Building 110, Liantang High-tech First Industrial Park, No. 72, Guowei Road, Xianhu Community, Liantang Sub-district, Luohu District, Shenzhen, CN-GD 518004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lens, spectacle (prescription), for reading discomfort MASK, SCAVENGING Sunglasses (non-prescription including photosensitive) Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) Frame, spectacle

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	2020-02-28
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-27
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2014-11-03
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-27
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2014-11-03

Official Correspondent

Micky Wu

US Agent Details

Rafi Wong Business: PACIFIC FORTUNE MANAGEMENT INC. Email: pfmservice@pfmfinance.com Phone: (408) 6466537

Related Public Records

Same Entity

Shenzhen Xinrun Optical Company 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
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

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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 3011307306. Last updated year: 2026. Please use registration number 3011307306 when referencing this establishment in official correspondence.