FDA 510(k)

AIR OPTIX COLORS

K-번호: K222500 · 2022-09-15

결정일2022-09-15

제품 코드LPL

자문 위원회OP

결정Substantially Equivalent

기기 요약

AIR OPTIX COLORS is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K222500. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AIR OPTIX COLORS?

AIR OPTIX COLORS is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K222500.

When did AIR OPTIX COLORS receive FDA 510(k) clearance?

AIR OPTIX COLORS received FDA 510(k) clearance on 2022-09-15, under 510(k) number K222500.

Who is the listed applicant for AIR OPTIX COLORS?

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

What is the FDA product code for AIR OPTIX COLORS?

The FDA product code for AIR OPTIX COLORS is LPL.

Alcon Laboratories, Inc.를 신청인으로 등재한 기타 기록

K254052DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal K252682LenSx Laser System (8065000944)K243896LenSx Laser System (8065998162)K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);K233876UNITY VCS (8065000296); UNITY CS (8065000297)

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관련 기기 (코드: LPL)

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