Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614761

FEI Number

1000188353

Entity Name

MENICON CO. LTD.

City/State/Country

NAGOYA Aichi, JP

Establishment Address

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

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K950878

PMA Number

N/A

All Registered Proprietary Names

MENICON Z RIGID GAS PERMEABLE CONTACT LENS Miru 1day Menicon Flat Pack Toric Miru 1day Menicon Flat Pack LacriPure Menicon Z Large Diameter MeniSept MENICON SP VIAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic	Class 3	886.5916	2007-11-09
MWL	Lens, Contact (Rigid Gas Permeable), Extended Wear	Ophthalmic	Class 3	886.5916	2007-11-09
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2011-05-08
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-01-15
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2016-01-15
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2011-08-30
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2021-07-14
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2021-07-14
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2011-11-01
LRX	Case, Contact Lens	Ophthalmic	Class 2	886.5928	2002-08-13

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
3002807570	Menicon Co., Ltd., Seki Plant	Seki Gifu, JP
3014768085	Menicon Co., Ltd., Kakamigahara Plant	Kakamigahara Gifu, JP
3009104180	Menicon Singapore Pte. Ltd.	Singapore South West, SG

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 9614761. Last updated year: 2026. Please use registration number 9614761 when referencing this establishment in official correspondence.