FDA 510(k)

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

N.º K: K161100 · 2016-08-10

Fecha de decisión2016-08-10

Código de productoHQD

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K161100. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses?

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Contamac, Ltd.. The 510(k) number is K161100.

When did Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses receive FDA 510(k) clearance?

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses received FDA 510(k) clearance on 2016-08-10, under 510(k) number K161100.

Who is the listed applicant for Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses?

The FDA 510(k) record lists Contamac, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses?

The FDA product code for Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses is HQD.

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Otros registros que enlistan a Contamac, Ltd. como solicitante

K212631Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses K182304Hyper GP (tisilfocon A) Daily Wear Contact Lens K181566Nutrifill K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens K171575ENFLU 18 (enflufocon A) Daily Wear Contact Lens K171077HEXA100 (hexafocon A) Daily Wear Contact Lenses

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Dispositivos relacionados (Código: HQD)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.