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FDA 510(k)

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens

K-Number: K200618 · 2020-12-07

ApplicantVisco Vision, Inc.
Decision Date2020-12-07
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens is a medical device manufactured by Visco Vision, Inc.. It received FDA 510(k) clearance on 2020-12-07 under approval number K200618. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Visco Vision, Inc.. The 510(k) number is K200618.

When was HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens approved by the FDA?

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

What company makes HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens?

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens is manufactured by Visco Vision, Inc..

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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Other Devices by Visco Vision, Inc.

K160245Visco (olifilcon A) soft contact lens K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 K171447OxyPure Color Silicone Hydrogel Soft Contact Lenses K181349Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel 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

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Related Devices (Code: LPL)

K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. K160245Visco (olifilcon A) soft contact lensVisco Vision, Inc. K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd. K162596AIR OPTIX COLORSAlcon Laboratories, Inc. K161931Toricolors (hioxifilcon D) Soft Contact LensesPolydev , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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