FDA 510(k)

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens

Número K: K200618 · 2020-12-07

Data da decisão2020-12-07

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

HydroSens A (hioxifilcon A) Spherical 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 2020-12-07 under 510(k) number K200618. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens?

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is Visco Vision, Inc.. The 510(k) number is K200618.

When did HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens receive FDA 510(k) clearance?

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens received FDA 510(k) clearance on 2020-12-07, under 510(k) number K200618.

Who is the listed applicant for HydroSens A (hioxifilcon A) Spherical 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 HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens?

The FDA product code for HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens is LPL.

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Outros registros que listam Visco Vision, Inc. como candidato(a)

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) com Silicone de Polímeros Tácteis; Lente de Contato Silicone de Polímeros Tácteis Diária Breeze (olifilcon B)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

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Dispositivos Relacionados (Código: LPL)

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