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PMA de la FDA

Extended depth of focus intraocular lens

Número de PMA: P210005 · 2026-07-14

SolicitanteAcu Focus, Inc.
Fecha de decisión2026-07-14
Número PMAP210005
Código de productoPOE
Clase del dispositivoClase 3
Especialidad médicaO
Número de regulación21 CFR 8
Comité asesorOP

Resumen del dispositivo

Extended depth of focus intraocular lens is the device name listed in this FDA 510(k) record. The listed applicant is Acu Focus, Inc.. It received FDA 510(k) clearance on 2026-07-14. The device is classified under product code POE. It was reviewed by the OP advisory panel.

Preguntas frecuentes

What is the Extended depth of focus intraocular lens?

Extended depth of focus intraocular lens is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Acu Focus, Inc..

When did Extended depth of focus intraocular lens receive FDA 510(k) clearance?

The clearance date for Extended depth of focus intraocular lens can be found in the official FDA records.

Who is the listed applicant for Extended depth of focus intraocular lens?

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

What is the FDA product code for Extended depth of focus intraocular lens?

The FDA product code for Extended depth of focus intraocular lens is POE.

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Fuente oficial

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