Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807570

FEI Number

3002807570

Entity Name

Menicon Co., Ltd., Seki Plant

City/State/Country

Seki Gifu, JP

Establishment Address

3, Shinhasama, --, Seki Gifu 501-3923, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MENICON CO. LTD. (Owner Number: 9001029)

Owner / Operator Contact Address

21-19 AOI, 3-CHOME, NAKA-KU, --, NAGOYA, JP-23 460-0006, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180004

PMA Number

N/A

All Registered Proprietary Names

Miru 1month Menicon (1Month SiHy)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2018-02-23

Official Correspondent

Zhu Jiang

US Agent Details

Alberty Recio Business: MENICON AMERICA, INC. Email: alberty_recio@menicon.com Phone: (781) 6092042

Related Public Records

Same Entity

MENICON CO. LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011861185	Menicon Singapore Pte. Ltd. (Site 2)	SINGAPORE South West, SG
3010413909	Menicon Nect Co., Ltd.	Nagoya Aichi, JP
3014768085	Menicon Co., Ltd., Kakamigahara Plant	Kakamigahara Gifu, JP
3009104180	Menicon Singapore Pte. Ltd.	Singapore South West, SG
3014769028	Menicon Co., Ltd. Techno-station	Kakamigahara Gifu, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17
K941998	Ocu-Ease Optical Products, Inc.	OCU-FLEX-38 (POLYMACON)	1994-10-13
K992500	Cantor & Silver , Ltd.	CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS	1999-08-18
K984098	Adventures IN Color Technology, Ltd.	ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS	1999-05-10
K003161	Les Laboratoires Blanchard	ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT	2000-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807570. Last updated year: 2026. Please use registration number 3002807570 when referencing this establishment in official correspondence.