FDA 510(k)

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

K-번호: K221768 · 2023-05-05

결정일2023-05-05

제품 코드HQD

자문 위원회OP

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: HQD)

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