Data / Medical devices / Japan / Menicon Nect Co., Ltd., Gujo Plant

Menicon Nect Co., Ltd., Gujo Plant: FDA-registered device maker in Gujo Gifu, Japan, 6 510(k) clearances and 1 PMA approval

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

Menicon Nect Co., Ltd., Gujo Plant is registered with the FDA (registration 3010607087) in Gujo Gifu, Japan. It lists 5 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated March 2, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010607087
Address: 15, Shimizumoto, Hachimancho-Asahi, Gujo Gifu, Japan, 501-4204
Owner or operator: MENICON CO. LTD. (9001029)
Roles: Manufacturer
First device listed: November 9, 2007
Registered through: 2026
Brand names listed: LacriPure, MENICON Z RIGID GAS PERMEABLE CONTACT LENS, MeniSept, Menicon Progent Protein Remover, Menicon Z DW, Menicon Z Irregular Cornea, Menicon Z Large Diameter

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Soft Lens Products	LPN	2	Manufacturer	accessdata.fda.gov
Lens, Contact (Other Material) - Daily	HQD	2	Manufacturer	accessdata.fda.gov
Lens, Contact (Rigid Gas Permeable), Extended Wear	MWL	3	Manufacturer	accessdata.fda.gov
Lens, Contact, Orthokeratology, Overnight	NUU	3	Manufacturer	accessdata.fda.gov
Products, Contact Lens Care, Rigid Gas Permeable	MRC	2	Manufacturer	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
March 2, 2020	K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	LPN	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
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
October 9, 1996	K962006	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Menicon Co, 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 June 16, 2023. 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.