FDA 510(k)

ACUVUE OASYS (senofilcon A) con Aditivo Fotocrómico

N.º K: K180299 · 2018-04-10

SolicitanteJohnson & Johnson Vision Care, Inc.

Fecha de decisión2018-04-10

Código de productoLPL

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACUVUE OASYS (senofilcon A) with Photochromic Additive is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Vision Care, Inc.. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K180299. 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 ACUVUE OASYS (senofilcon A) with Photochromic Additive?

ACUVUE OASYS (senofilcon A) with Photochromic Additive is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Johnson & Johnson Vision Care, Inc.. The 510(k) number is K180299.

When did ACUVUE OASYS (senofilcon A) with Photochromic Additive receive FDA 510(k) clearance?

ACUVUE OASYS (senofilcon A) with Photochromic Additive received FDA 510(k) clearance on 2018-04-10, under 510(k) number K180299.

Who is the listed applicant for ACUVUE OASYS (senofilcon A) with Photochromic Additive?

The FDA 510(k) record lists Johnson & Johnson Vision Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUVUE OASYS (senofilcon A) with Photochromic Additive?

The FDA product code for ACUVUE OASYS (senofilcon A) with Photochromic Additive is LPL.

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Otros registros que enlistan a Johnson & Johnson Vision Care, Inc. como solicitante

K210930ACUVUE® OASYS MAX 1-DAY Lentes de Contacto (senofilcon A)K200243ACUVUE (senofilcon A) Lente de Contacto Suave Multifocal K160212ACUVUE (senofilcon C) Lente de Contacto Suave

Dispositivos relacionados (Código: LPL)

Fuente oficial

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