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FDA 510(k)

AIR OPTIX COLORS

K-Number: K222500 · 2022-09-15

ApplicantAlcon Laboratories, Inc.
Decision Date2022-09-15
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AIR OPTIX COLORS is a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2022-09-15 under approval number K222500. 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 AIR OPTIX COLORS?

AIR OPTIX COLORS is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K222500.

When was AIR OPTIX COLORS approved by the FDA?

AIR OPTIX COLORS received FDA 510(k) clearance on 2022-09-15, under approval number K222500.

What company makes AIR OPTIX COLORS?

AIR OPTIX COLORS is manufactured by Alcon Laboratories, Inc..

What is the FDA product code for AIR OPTIX COLORS?

The FDA product code for AIR OPTIX COLORS is LPL.

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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