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FDA 510(k)

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

K-Number: K210975 · 2021-05-24

ApplicantBausch & Lomb, Incorporated
Decision Date2021-05-24
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is a medical device manufactured by Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2021-05-24 under approval number K210975. 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 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia?

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is a medical device that received FDA 510(k) clearance on 2021-05-24. It is manufactured by Bausch & Lomb, Incorporated. The 510(k) number is K210975.

When was Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia approved by the FDA?

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia received FDA 510(k) clearance on 2021-05-24, under approval number K210975.

What company makes Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia?

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is manufactured by Bausch & Lomb, Incorporated.

What is the FDA product code for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia?

The FDA product code for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is LPL.

Related Clinical Trials

NCT07559188 Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus NOT_YET_RECRUITING

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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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