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FDA PMA

Femtosecond laser system for refractive correction

PMA Number: P150040 · 2026-05-26

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2026-05-26
PMA NumberP150040
Product CodeOTL
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOP

Device Summary

Femtosecond laser system for refractive correction is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2026-05-26. The device is classified under product code OTL. It was reviewed by the OP advisory panel.

Frequently Asked Questions

What is the Femtosecond laser system for refractive correction?

Femtosecond laser system for refractive correction is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Carl Zeiss Meditec, Inc..

When did Femtosecond laser system for refractive correction receive FDA 510(k) clearance?

The clearance date for Femtosecond laser system for refractive correction can be found in the official FDA records.

Who is the listed applicant for Femtosecond laser system for refractive correction?

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

What is the FDA product code for Femtosecond laser system for refractive correction?

The FDA product code for Femtosecond laser system for refractive correction is OTL.

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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