Data / Medical devices / Japan / Menicon Co. Ltd.

Menicon Co. Ltd.: FDA-registered device maker in NAGOYA Aichi, Japan, 16 510(k) clearances and 1 PMA approval

Name: Menicon Co. Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Menicon Co. Ltd. is registered with the FDA (registration 9614761) in NAGOYA Aichi, Japan. It lists 8 device types. The FDA files 16 510(k) clearances and 1 PMA approval under its listings, the newest dated September 17, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614761
FEI number: 1000188353
Address: 21-19 Aoi, 3-Chome, Naka-Ku, NAGOYA Aichi, Japan, 460-0006
Owner or operator: MENICON CO. LTD. (9001029)
Roles: Complaint file establishment
First device listed: August 13, 2002
Registered through: 2026
Brand names listed: LacriPure, MENICON SP VIAL, MENICON Z RIGID GAS PERMEABLE CONTACT LENS, MeniSept, Menicon Nect Contact Lens Case, Menicon Progent Protein Remover, Menicon Unique pH Multi-Purpose Solution, Menicon Z DW and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Soft Lens Products	LPN	2	Complaint file establishment	accessdata.fda.gov
Case, Contact Lens	LRX	2	Complaint file establishment	accessdata.fda.gov
Lens, Contact (Other Material) - Daily	HQD	2	Complaint file establishment	accessdata.fda.gov
Lens, Contact (Rigid Gas Permeable), Extended Wear	MWL	3	Complaint file establishment	accessdata.fda.gov
Lens, Contact, (Disposable)	MVN	2	Complaint file establishment	accessdata.fda.gov
Lens, Contact, Orthokeratology, Overnight	NUU	3	Complaint file establishment	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Complaint file establishment	accessdata.fda.gov
Products, Contact Lens Care, Rigid Gas Permeable	MRC	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 17, 2026	K262495	Miru 1day UpSide (midafilcon A)	LPL	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
June 17, 2020	K193399	Miru 1day UpSide (midafilcon A)	LPL	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
March 2, 2020	K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	LPN	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
February 22, 2018	K180004	Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens	LPL	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
November 16, 2017	K173136	Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses	MRC	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
August 28, 2015	K151768	Menicon Saline Rinse Solution	LPN	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
August 6, 2013	K131875	MENICON NECT CONTACT LENS CASE	LRX	Substantially Equivalent	Foresight Regulatory Strategies	accessdata.fda.gov
July 3, 2013	K130805	MENICON UNIQUE PH MULTI-PURPOSE SOLUTION	MRC	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
April 3, 2013	K130285	PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS	LRX	Substantially Equivalent	The Lagado Corp.	accessdata.fda.gov
April 28, 2011	K102895	ONE DAY FLAT PACK	LPL	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
February 3, 2011	K103561	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
September 23, 2008	K081443	MENICON Z RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
May 30, 2002	K013646	ROSE K POST GRAFT LENS	HQD	Substantially Equivalent	Rose K International , Ltd.	accessdata.fda.gov
October 9, 1996	K962006	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Menicon Co, Ltd.	accessdata.fda.gov
April 7, 1995	K950878	MENICON SP VIAL	LRX	Substantially Equivalent	Hyman, Phelps & McNamara, P.C.	accessdata.fda.gov
February 7, 1995	K945955	ROSE K LENS	HQD	Substantially Equivalent	Rose K International , Ltd.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 11, 2000	P990018	MENICON Z RIGID GAS PERMEABLE CONTACT LENS	MWL	10	June 16, 2023	accessdata.fda.gov

Compare with other makers

Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.