FDA 510(k)

DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric

Número K: K232921 · 2023-11-16

Data da decisão2023-11-16

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric 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 2023-11-16 under 510(k) number K232921. 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 DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric?

DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K232921.

When did DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric receive FDA 510(k) clearance?

DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric received FDA 510(k) clearance on 2023-11-16, under 510(k) number K232921.

Who is the listed applicant for DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric?

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 TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric?

The FDA product code for DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric is LPL.

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Outros registros que listam Alcon Laboratories, Inc. como candidato(a)

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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Dispositivos Relacionados (Código: LPL)

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