FDA 510(k)

OxySoft (olifilcon C) silicone hydrogel soft contact lens

K-Nummer: K191397 · 2019-10-02

Entscheidungsdatum2019-10-02

ProduktcodeLPL

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

OxySoft (olifilcon C) 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 2019-10-02 under 510(k) number K191397. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the OxySoft (olifilcon C) silicone hydrogel soft contact lens?

OxySoft (olifilcon C) silicone hydrogel soft contact lens is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Visco Vision, Inc.. The 510(k) number is K191397.

When did OxySoft (olifilcon C) silicone hydrogel soft contact lens receive FDA 510(k) clearance?

OxySoft (olifilcon C) silicone hydrogel soft contact lens received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191397.

Who is the listed applicant for OxySoft (olifilcon C) 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 OxySoft (olifilcon C) silicone hydrogel soft contact lens?

The FDA product code for OxySoft (olifilcon C) silicone hydrogel soft contact lens is LPL.

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Weitere Einträge mit Visco Vision, Inc. als Antragsteller

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 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) mit Tangible Polymers Silikonhydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silikonhydrogel Soft Contact Lens K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lens 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

Alle 10 Geräte anzeigen →

Verwandte Geräte (Code: LPL)

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