Menicon Z Rigid Gas Permeable Contact Lens

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P990018510(k) K081443

by Menicon Co., Ltd.

Identity

Trade Name: MENICON Z RIGID GAS PERMEABLE CONTACT LENS FDA PMA
Generic Name: Lens, contact (rigid gas permeable), extended wear FDA PMA

Identifiers

PMA Number: P990018 FDA PMA
510(k) Number: K081443 FDA PMA
FDA Product Code: HQD FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 886.5916 FDA PMA
Regulation Number: 886.5916 FDA PMA
Advisory Committee: Ophthalmic FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The Menicon Z is a rigid gas permeable contact lens, also known as Tisilfocon A, designed for the correction of refractive errors including myopia, hyperopia, presbyopia, and astigmatism. It is available in spherical, aspheric, and non-prism ballast toric lens designs for use in non-aphakic persons with non-diseased eyes.

These lenses are indicated for extended wear, allowing for use from one to seven days between removals for cleaning and disinfection as recommended by an eyecare practitioner. The device is regulated under the ophthalmic medical specialty and has received FDA authorization for its intended use in vision correction.

Frequently asked questions

What conditions can the Menicon Z lens correct?

The Menicon Z rigid gas permeable contact lens is indicated for the correction of refractive errors, specifically myopia, hyperopia, presbyopia, and astigmatism in non-aphakic individuals.

How long can I wear the Menicon Z lenses?

These lenses are indicated for extended wear, which means they can be worn for a period ranging from one to seven days between removals for cleaning and disinfection, depending on the specific recommendation of your eyecare practitioner.

What material is the Menicon Z made of?

The Menicon Z is a rigid gas permeable contact lens manufactured from the material Tisilfocon A.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Menicon Corporate Website

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K081443	Class III	Active
FDA PMA	United States	FDA_PMA	P990018	Class III	Active

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Manufacturer

Manufacturer: Menicon Co., Ltd.
FDA Applicant: Menicon Co, Ltd.

Sources (2)

FDA PMA P990018 37 fields · synced Sep 18, 2026
FDA 510(k) K081443 1 fields · synced May 18, 2026