FDA 510(k)

Optixon 1-Day

N.º K: K201013 · 2020-09-18

Fecha de decisión2020-09-18

Código de productoLPL

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

Optixon 1-Day is the device name listed in this FDA 510(k) record. The listed applicant is Optixon, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201013. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Optixon 1-Day?

Optixon 1-Day is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Optixon, Inc.. The 510(k) number is K201013.

When did Optixon 1-Day receive FDA 510(k) clearance?

Optixon 1-Day received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201013.

Who is the listed applicant for Optixon 1-Day?

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

What is the FDA product code for Optixon 1-Day?

The FDA product code for Optixon 1-Day is LPL.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: LPL)

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