FDA 510(k)

Optixon 1-Day

K-Nummer: K201013 · 2020-09-18

Entscheidungsdatum2020-09-18

ProduktcodeLPL

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: LPL)

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