Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030294

FEI Number

3003672538

Entity Name

NAKANISHI OPTICAL PRODUCTS CORP.

City/State/Country

OSAKA, JP

Establishment Address

NO. 1 OSAKA EKIMAE BLDG., 3-1-200, UMEDA, 1-CHOME, KITA-KU, OSAKA 5300001, JP

Establishment Type(s)

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

Owner / Operator

NAKANISHI OPTICAL PRODUCTS CORP. (Owner Number: 8030294)

Owner / Operator Contact Address

NO. 1 OSAKA EKIMAE BLDG., 3-1-200, UMEDA, 1-CHOME, KITA-KU, OSAKA, JP-27 5300001, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ROKA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	1981-03-19
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1985-06-03
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1977-12-28

Official Correspondent

SEIICHI SAEKI

US Agent Details

LISA WRIGHT Business: THE VISION COUNCIL Email: fda@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

NAKANISHI OPTICAL PRODUCTS CORP.

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

Similar Registrations

Registration Number	Establishment Name	Location
3006755718	DONGGUAN YUEHENG OPTICAL CO. LTD.	Dongguan Guangdong, CN
3015534032	BOLLE SAFETY INC	Carlsbad, CA, US
3007675955	Carl Zeiss Vision Canada, Inc.	Toronto Ontario, CA
1000428458	GKB OPHTHALMICS LIMITED - UNIT II	North Goa Goa, IN
3038136215	MEIVISION (VIETNAM) CO., LTD	Ho Chi Minh City, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030294. Last updated year: 2026. Please use registration number 8030294 when referencing this establishment in official correspondence.