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FDA PMA

Femtosecond laser system for refractive correction

Número do PMA: P150040 · 2026-05-26

RequerenteCarl Zeiss Meditec, Inc.
Data da decisão2026-05-26
Número PMAP150040
Código do produtoOTL
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoOP

Resumo do dispositivo

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.

Perguntas frequentes

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.

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