FDA PMA

Excimer laser system

Número do PMA: P910062 · 2019-04-12

RequerenteAmo Manufacturing USA, LLC

Data da decisão2019-04-12

Número PMAP910062

Código do produtoLZS

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoOP

Resumo do dispositivo

Excimer laser system is the device name listed in this FDA 510(k) record. The listed applicant is Amo Manufacturing USA, LLC. It received FDA 510(k) clearance on 2019-04-12. The device is classified under product code LZS. It was reviewed by the OP advisory panel.

Perguntas frequentes

What is the Excimer laser system?

Excimer laser system is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Amo Manufacturing USA, LLC.

When did Excimer laser system receive FDA 510(k) clearance?

The clearance date for Excimer laser system can be found in the official FDA records.

Who is the listed applicant for Excimer laser system?

The FDA 510(k) record lists Amo Manufacturing USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Excimer laser system?

The FDA product code for Excimer laser system is LZS.

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Fonte oficial

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