FDA 510(k)

Acuity 200 (플루로오시포콘 A) 고정형 가스 투과성隐形眼镜

K-번호: K203571 · 2021-04-09

결정일2021-04-09

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 2021-04-09 under 510(k) number K203571. 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 2021-04-09. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K203571.

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 2021-04-09, under 510(k) number K203571.

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.

Acuity Polymers, Inc.를 신청인으로 등재한 기타 기록

11개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.