FDA 510(k)

Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric

N.º K: K243909 · 2025-01-13

Fecha de decisión2025-01-13

Código de productoLPL

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; 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 2025-01-13 under 510(k) number K243909. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric?

Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K243909.

When did Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric receive FDA 510(k) clearance?

Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243909.

Who is the listed applicant for Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; 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 Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric?

The FDA product code for Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric is LPL.

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Otros registros que enlistan a Alcon Laboratories, Inc. como solicitante

K254052DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal K252682LenSx Laser System (8065000944)K243896LenSx Laser System (8065998162)K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);K233876UNITY VCS (8065000296); UNITY CS (8065000297)K233902Centurion™ Vision System (Active Sentry™) (8065753057)

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Dispositivos relacionados (Código: LPL)

Fuente oficial

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