FDA 510(k)

Acuity 200™ (플루로오시포콘 A) 고정형 가스 투과성隐形眼镜

K-번호: K201194 · 2020-09-08

결정일2020-09-08

제품 코드HQD

자문 위원회OP

결정Substantially Equivalent

기기 요약

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Polymers, Inc.. It received FDA 510(k) clearance on 2020-09-08 under 510(k) number K201194. 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is a medical device that received FDA 510(k) clearance on 2020-09-08. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K201194.

When did Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens receive FDA 510(k) clearance?

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance on 2020-09-08, under 510(k) number K201194.

Who is the listed applicant for Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

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

What is the FDA product code for Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

The FDA product code for Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is HQD.

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