FDA 510(k)

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

Número K: K221768 · 2023-05-05

Data da decisão2023-05-05

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Vision Sciences, Inc.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K221768. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses?

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Paragon Vision Sciences, Inc.. The 510(k) number is K221768.

When did Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses receive FDA 510(k) clearance?

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses received FDA 510(k) clearance on 2023-05-05, under 510(k) number K221768.

Who is the listed applicant for Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses?

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

What is the FDA product code for Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses?

The FDA product code for Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses is HQD.

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Dispositivos Relacionados (Código: HQD)

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Fonte oficial

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