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FDA PMA

Lens, multifocal intraocular

PMA Number: P200020 · 2026-04-15

ApplicantLenstec, Inc.
Decision Date2026-04-15
PMA NumberP200020
Product CodeMFK
Device ClassClass 3
Medical SpecialtyO
Regulation Number21 CFR 8
Advisory CommitteeOP

Device Summary

Lens, multifocal intraocular is the device name listed in this FDA 510(k) record. The listed applicant is Lenstec, Inc.. It received FDA 510(k) clearance on 2026-04-15. The device is classified under product code MFK. It was reviewed by the OP advisory panel.

Frequently Asked Questions

What is the Lens, multifocal intraocular?

Lens, multifocal intraocular is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Lenstec, Inc..

When did Lens, multifocal intraocular receive FDA 510(k) clearance?

The clearance date for Lens, multifocal intraocular can be found in the official FDA records.

Who is the listed applicant for Lens, multifocal intraocular?

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

What is the FDA product code for Lens, multifocal intraocular?

The FDA product code for Lens, multifocal intraocular is MFK.

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Official Source

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

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