FDA 510(k)

OxyPure Color Silicone Hydrogel Soft Contact Lenses

N.º K: K171447 · 2017-12-05

Fecha de decisión2017-12-05

Código de productoLPL

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

OxyPure Color Silicone Hydrogel Soft Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2017-12-05 under 510(k) number K171447. 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 OxyPure Color Silicone Hydrogel Soft Contact Lenses?

OxyPure Color Silicone Hydrogel Soft Contact Lenses is a medical device that received FDA 510(k) clearance on 2017-12-05. The listed applicant is Visco Vision, Inc.. The 510(k) number is K171447.

When did OxyPure Color Silicone Hydrogel Soft Contact Lenses receive FDA 510(k) clearance?

OxyPure Color Silicone Hydrogel Soft Contact Lenses received FDA 510(k) clearance on 2017-12-05, under 510(k) number K171447.

Who is the listed applicant for OxyPure Color Silicone Hydrogel Soft Contact Lenses?

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

What is the FDA product code for OxyPure Color Silicone Hydrogel Soft Contact Lenses?

The FDA product code for OxyPure Color Silicone Hydrogel Soft Contact Lenses is LPL.

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Otros registros que enlistan a Visco Vision, Inc. como solicitante

K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens K201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens K191397OxySoft (olifilcon C) silicone hydrogel soft contact lens K183670Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens K181349Vexillum (olifilcon B) con Lente de Contacto Suave de Silicona Hidrogel Tangible; Daily Breeze (olifilcon B) Lente de Contacto Suave de Silicona Hidrogel K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: LPL)

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.