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FDA 510(k)

Miru 1day UpSide (midafilcon A)

K-Number: K193399 · 2020-06-17

ApplicantMenicon Co, Ltd.
Decision Date2020-06-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Miru 1day UpSide (midafilcon A) is a medical device manufactured by Menicon Co, Ltd.. It received FDA 510(k) clearance on 2020-06-17 under approval number K193399. 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 Miru 1day UpSide (midafilcon A)?

Miru 1day UpSide (midafilcon A) is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Menicon Co, Ltd.. The 510(k) number is K193399.

When was Miru 1day UpSide (midafilcon A) approved by the FDA?

Miru 1day UpSide (midafilcon A) received FDA 510(k) clearance on 2020-06-17, under approval number K193399.

What company makes Miru 1day UpSide (midafilcon A)?

Miru 1day UpSide (midafilcon A) is manufactured by Menicon Co, Ltd..

What is the FDA product code for Miru 1day UpSide (midafilcon A)?

The FDA product code for Miru 1day UpSide (midafilcon A) is LPL.

Other Devices by Menicon Co, Ltd.

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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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