FDA 510(k)

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

Número K: K153643 · 2016-01-20

Data da decisão2016-01-20

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES 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 2016-01-20 under 510(k) number K153643. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives?

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K153643.

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

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives received FDA 510(k) clearance on 2016-01-20, under 510(k) number K153643.

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

The FDA product code for Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives is LPL.

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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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Fonte oficial

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