FDA 510(k)

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal

Número K: K233856 · 2023-12-29

Data da decisão2023-12-29

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal 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 2023-12-29 under 510(k) number K233856. 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 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal?

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K233856.

When did Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal receive FDA 510(k) clearance?

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal received FDA 510(k) clearance on 2023-12-29, under 510(k) number K233856.

Who is the listed applicant for Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal?

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; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal?

The FDA product code for Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal 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)

Ver todos os 37 dispositivos →

Dispositivos Relacionados (Código: LPL)

Fonte oficial

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