FDA 510(k)

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

N.º K: K180322 · 2018-04-20

Fecha de decisión2018-04-20

Código de productoLPL

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens 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 2018-04-20 under 510(k) number K180322. 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 Si-Hy (olifilcon B) color silicone hydrogel soft contact lens?

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Visco Vision, Inc.. The 510(k) number is K180322.

When did Si-Hy (olifilcon B) color silicone hydrogel soft contact lens receive FDA 510(k) clearance?

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180322.

Who is the listed applicant for Si-Hy (olifilcon B) color silicone hydrogel soft contact lens?

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 Si-Hy (olifilcon B) color silicone hydrogel soft contact lens?

The FDA product code for Si-Hy (olifilcon B) color silicone hydrogel soft contact lens 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 K173958OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens

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Dispositivos relacionados (Código: LPL)

Fuente oficial

Ver en la base de datos de la FDA →

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