Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808383

FEI Number

3002808383

Entity Name

Topcon Yamagata Co., LTD West Factory

City/State/Country

Yamagata-ken, JP

Establishment Address

270-2 Oaza Urushiyama, Yamagata-shi, Yamagata-ken 990-2196, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Topcon Healthcare, Inc. (Owner Number: 9031569)

Owner / Operator Contact Address

111 Bauer Drive, Oakland, NJ 07436, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACP-8 ACP-8R

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2003-10-06

Official Correspondent

No official correspondent registered.

US Agent Details

Susan Quick Business: Topcon Healthcare, Inc. Email: tmsregulatory@topcon.com Phone: (216) 7805532

Related Public Records

Same Entity

Topcon Healthcare, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2242863	Topcon Healthcare, Inc.	Oakland, NJ, US
9614661	TOPCON CORP.	TOKYO, JP
3008729548	Topcon Yamagata Co., LTD	Yamagata-KEN, JP

Similar Registrations

Registration Number	Establishment Name	Location
9614661	TOPCON CORP.	TOKYO, JP
3010363281	EVERVIEW CORP	Geumcheon-gu Seoul, KR
3009515444	GINO OPTICAL (SHANGHAI) CO., LTD.	Shanghai, CN
3033566	OCULUS, INC.	Arlington, WA, US
3015972897	INNOVA MEDICAL OPHTHALMICS	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808383. Last updated year: 2026. Please use registration number 3002808383 when referencing this establishment in official correspondence.