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FDA PMA

Lens, contact (rigid gas permeable), extended wear

PMA Number: P990018 · 2023-06-16

ApplicantMenicon Co, Ltd.
Decision Date2023-06-16
PMA NumberP990018
Product CodeMWL
Device ClassClass 3
Medical SpecialtyO
Regulation Number21 CFR 8
Advisory CommitteeOP

Device Summary

Lens, contact (rigid gas permeable), extended wear is the device name listed in this FDA 510(k) record. The listed applicant is Menicon Co, Ltd.. It received FDA 510(k) clearance on 2023-06-16. The device is classified under product code MWL. It was reviewed by the OP advisory panel.

Frequently Asked Questions

What is the Lens, contact (rigid gas permeable), extended wear?

Lens, contact (rigid gas permeable), extended wear is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Menicon Co, Ltd..

When did Lens, contact (rigid gas permeable), extended wear receive FDA 510(k) clearance?

The clearance date for Lens, contact (rigid gas permeable), extended wear can be found in the official FDA records.

Who is the listed applicant for Lens, contact (rigid gas permeable), extended wear?

The FDA 510(k) record lists Menicon Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lens, contact (rigid gas permeable), extended wear?

The FDA product code for Lens, contact (rigid gas permeable), extended wear is MWL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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