FDA PMA

Lens, intraocular, phakic

Número do PMA: P030028 · 2026-04-24

RequerenteOphtec BV

Data da decisão2026-04-24

Número PMAP030028

Código do produtoMTA

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoOP

Resumo do dispositivo

Lens, intraocular, phakic is the device name listed in this FDA 510(k) record. The listed applicant is Ophtec BV. It received FDA 510(k) clearance on 2026-04-24. The device is classified under product code MTA. It was reviewed by the OP advisory panel.

Perguntas frequentes

What is the Lens, intraocular, phakic?

Lens, intraocular, phakic is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Ophtec BV.

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

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

Who is the listed applicant for Lens, intraocular, phakic?

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

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

The FDA product code for Lens, intraocular, phakic is MTA.

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Fonte oficial

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