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FDA 510(k)

Alcon (serafilcon A) soft contact lenses for daily wear

K-Number: K212806 · 2021-12-28

ApplicantAlcon Laboratories, Inc.
Decision Date2021-12-28
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Alcon (serafilcon A) soft contact lenses for daily wear is a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-12-28 under approval number K212806. 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 Alcon (serafilcon A) soft contact lenses for daily wear?

Alcon (serafilcon A) soft contact lenses for daily wear is a medical device that received FDA 510(k) clearance on 2021-12-28. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K212806.

When was Alcon (serafilcon A) soft contact lenses for daily wear approved by the FDA?

Alcon (serafilcon A) soft contact lenses for daily wear received FDA 510(k) clearance on 2021-12-28, under approval number K212806.

What company makes Alcon (serafilcon A) soft contact lenses for daily wear?

Alcon (serafilcon A) soft contact lenses for daily wear is manufactured by Alcon Laboratories, Inc..

What is the FDA product code for Alcon (serafilcon A) soft contact lenses for daily wear?

The FDA product code for Alcon (serafilcon A) soft contact lenses for daily wear is LPL.

Related Clinical Trials

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Other Devices by Alcon Laboratories, Inc.

K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives K161288LenSX Laser System K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc K162596AIR OPTIX COLORS K160609AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

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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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