FDA 510(k)

Precision1, Precision1 for Astigmatism

K-번호: K230785 · 2023-04-20

결정일2023-04-20

제품 코드LPL

자문 위원회OP

결정Substantially Equivalent

기기 요약

Precision1, Precision1 for Astigmatism 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 2023-04-20 under 510(k) number K230785. 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 Precision1, Precision1 for Astigmatism?

Precision1, Precision1 for Astigmatism is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K230785.

When did Precision1, Precision1 for Astigmatism receive FDA 510(k) clearance?

Precision1, Precision1 for Astigmatism received FDA 510(k) clearance on 2023-04-20, under 510(k) number K230785.

Who is the listed applicant for Precision1, Precision1 for Astigmatism?

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 Precision1, Precision1 for Astigmatism?

The FDA product code for Precision1, Precision1 for Astigmatism 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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