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FDA 510(k)

MyDay

K-Number: K190965 · 2019-04-29

ApplicantCooperVision, Inc.
Decision Date2019-04-29
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MyDay is a medical device manufactured by CooperVision, Inc.. It received FDA 510(k) clearance on 2019-04-29 under approval number K190965. 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 MyDay?

MyDay is a medical device that received FDA 510(k) clearance on 2019-04-29. It is manufactured by CooperVision, Inc.. The 510(k) number is K190965.

When was MyDay approved by the FDA?

MyDay received FDA 510(k) clearance on 2019-04-29, under approval number K190965.

What company makes MyDay?

MyDay is manufactured by CooperVision, Inc..

What is the FDA product code for MyDay?

The FDA product code for MyDay is LPL.

Other Devices by CooperVision, Inc.

K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker K202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC K213164Avaira Vitality K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) 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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