Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010214

FEI Number

3003225753

Entity Name

FUKUSHIMA OPTICAL MFG., INC.

City/State/Country

Sabae Fukui, JP

Establishment Address

6-45, 2-CHOME, KAMINAKA-CHO, Sabae Fukui 916-0016, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUKUSHIMA OPTICAL MFG., INC. (Owner Number: 8010214)

Owner / Operator Contact Address

6-45, 2-CHOME, KAMINAKA-CHO, --, SABAE CITY, FUKUI-PREF., JP-NOTA 916-0016, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OPTICAL FRAME

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1984-12-12

Official Correspondent

HARUKAZU FUKUSHIMA

US Agent Details

CATHY KAYE Business: CLEAR VISION OPTICAL COMPANY INC. USA Email: ckaye@cvoptical.com Phone: (631) 7871681

Related Public Records

Same Entity

FUKUSHIMA OPTICAL MFG., INC.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010214. Last updated year: 2026. Please use registration number 8010214 when referencing this establishment in official correspondence.