Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001762432

FEI Number

3001762432

Entity Name

IKETANI Co., Ltd.

City/State/Country

Kiso-gun, Nagano-KEN, JP

Establishment Address

2196 Hiyoshi, Kiso-machi, Kiso-gun, Nagano-KEN 399-6101, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IKETANI Co., Ltd. (Owner Number: 10053328)

Owner / Operator Contact Address

2196 Hiyoshi, Kiso-machi, Kiso-gun, JP-20 3996101, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TLS; TLS-AF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2016-11-22

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

IKETANI 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
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21

Similar Registrations

Registration Number	Establishment Name	Location
3003039352	EPSILON EYE CARE PVT., LTD.	MUMBAI Maharashtra, IN
8040382	PAUL INSTRUMENTS (INDIA)	CALCUTTA West Bengal, IN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
3003951061	M/S TARUN ENTERPRISES	Prayagraj, Uttar Pradesh, IN
5470	H. OGINO & CO., LTD.	Yokohama Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001762432. Last updated year: 2026. Please use registration number 3001762432 when referencing this establishment in official correspondence.