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Menicon Z Contact Lens

by Menicon U.S.A., Inc.

510(k) K000133

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000133 Date19 May 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Menicon Z
510(k) Number
FDA Product Code
HQD
Device Class
Class II
Regulation
21 CFR Part 886.5916
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Menicon Z is a daily-wear contact lens designed for ophthalmic use, classified as a contact lens made from other materials. It is intended for correction of refractive errors and may be used for cosmetic purposes, providing clear vision without the need for glasses or frames.

Supplied as single-use lenses, the Menicon Z is intended for daily wear and disposal. It is regulated under FDA 510(k) clearance (K000133) as a Class II device, adhering to regulatory standards for ophthalmic contact lenses. Available in various sizes and prescriptions, it must be stored and handled according to manufacturer guidelines to ensure sterility and safety. No MRI safety information is specified.

Other devices from Menicon U.S.A., Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are the Menicon Z lenses reusable, or are they meant for single-use only?

    The Menicon Z lenses are designed for single-use only, meaning each lens is intended for one day of wear and disposal. This aligns with their classification as a daily-wear contact lens, ensuring sterility and safety for each use without the need for cleaning or reprocessing.

  • What types of refractive errors can the Menicon Z correct, and can they also be used for cosmetic purposes?

    The Menicon Z is intended for correction of refractive errors (such as myopia, hyperopia, or astigmatism) and may also be used for cosmetic purposes, like enhancing appearance without glasses or frames. Its design provides clear vision while accommodating various prescriptions.

  • How should the Menicon Z lenses be stored to maintain sterility and safety?

    The Menicon Z lenses must be stored and handled according to the manufacturer’s guidelines to ensure sterility and safety. Since they are single-use, they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until use, following the packaging instructions provided by Menicon U.S.A., Inc.

  • What regulatory pathway was followed for FDA clearance of the Menicon Z, and what class does it belong to?

    The Menicon Z was cleared via a traditional 510(k) pathway (K000133) and is classified as a Class II device under FDA regulations. This classification applies to contact lenses made from other materials, ensuring it meets stringent standards for ophthalmic use.

  • Are there multiple sizes or prescriptions available for the Menicon Z, and how do I determine the correct fit?

    Yes, the Menicon Z is available in various sizes and prescriptions to accommodate different vision needs. The correct fit depends on the patient’s refractive error and corneal curvature, so it’s essential to follow an eye care professional’s prescription and recommendations to ensure proper vision correction and comfort.