FDA 510(k)

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives

K-번호: K190045 · 2019-02-06

결정일2019-02-06

제품 코드LPL

자문 위원회OP

결정Substantially Equivalent

기기 요약

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives 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 2019-02-06 under 510(k) number K190045. 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 DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives?

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives is a medical device that received FDA 510(k) clearance on 2019-02-06. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K190045.

When did DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives receive FDA 510(k) clearance?

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives received FDA 510(k) clearance on 2019-02-06, under 510(k) number K190045.

Who is the listed applicant for DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives?

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 DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives?

The FDA product code for DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives 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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