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FDA 510(k)

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)

K-Number: K181656 · 2019-03-05

ApplicantEyemed Technologies S.R.L.
Decision Date2019-03-05
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) is a medical device manufactured by Eyemed Technologies S.R.L.. It received FDA 510(k) clearance on 2019-03-05 under approval number K181656. 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 ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)?

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) is a medical device that received FDA 510(k) clearance on 2019-03-05. It is manufactured by Eyemed Technologies S.R.L.. The 510(k) number is K181656.

When was ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) approved by the FDA?

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) received FDA 510(k) clearance on 2019-03-05, under approval number K181656.

What company makes ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)?

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) is manufactured by Eyemed Technologies S.R.L..

What is the FDA product code for ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)?

The FDA product code for ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) is LPL.

Related Clinical Trials

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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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