Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042972016

FEI Number

3042972016

Entity Name

SEKI GANKYO SEISAKUSHO K.K

City/State/Country

Sabae city Fukui, JP

Establishment Address

25-43, Kawadacho, Sabae city Fukui 916-1222, JP

Establishment Type(s)

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

Owner / Operator

SEKI Gankyo Seisakusho K.K (Owner Number: 10094809)

Owner / Operator Contact Address

25-43, Kawadacho, Sabae city, JP-18 916-1222, 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
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2025-12-24
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-12-24

Official Correspondent

Toshiaki Seki

US Agent Details

Avon Ray Business: Jacques Marie Mage Inc Email: avon@jacquesmariemage.com Phone: (213) 3860087

Related Public Records

Same Entity

SEKI Gankyo Seisakusho K.K

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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3003846146	PRECISION VISION	Woodstock, IL, US
3013003882	EYEQUE CORPORATION	Newark, CA, US
3020723591	OCULUS Florida Service Center	Port Saint Lucie, FL, US
8030207	OPTICA FUKUI, INC.	SABAE CITY, FUKUI PREF., JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042972016. Last updated year: 2026. Please use registration number 3042972016 when referencing this establishment in official correspondence.