Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003515967

FEI Number

3003515967

Entity Name

MENICON AMERICA, INC.

City/State/Country

North Billerica, MA, US

Establishment Address

76 Treble Cove Rd., Bldg. #3, North Billerica, MA 01862, US

Establishment Type(s)

Repack or Relabel 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

K193399

PMA Number

N/A

All Registered Proprietary Names

Menicon Progent Protein Remover Menicon Unique pH Multi-Purpose Solution Miru 1month Menicon (1Month SiHy) Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens Miru 1day UpSide (1 Day SiHy)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2020-07-21
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2013-07-07
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2018-02-23
LRX	Case, Contact Lens	Ophthalmic	Class 2	886.5928	2016-02-08
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-07-02
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2020-07-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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-0030-2022	Contamac Solutions, Inc.	2	Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
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.

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3004178847	AMO (HANGZHOU) CO., LTD.	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003515967. Last updated year: 2026. Please use registration number 3003515967 when referencing this establishment in official correspondence.