Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018161212

FEI Number

3018161212

Entity Name

OOGEN CO., LTD

City/State/Country

Sabae City Fukui, JP

Establishment Address

2-507, Higashisabae, Sabae City Fukui 916-0041, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

oogen co., ltd (Owner Number: 10080978)

Owner / Operator Contact Address

2-507, Higashisabae,, Sabae City, JP-18 916-0041, JP

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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2021-03-09
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2021-03-09
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2021-03-09

Official Correspondent

Wing Yi Lam

US Agent Details

Lisa Wright Business: The Vision Council Email: fda@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

oogen co., 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 3018161212. Last updated year: 2026. Please use registration number 3018161212 when referencing this establishment in official correspondence.