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FDA 510(k)

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism

K-Number: K200528 · 2020-06-02

ApplicantBausch + Lomb, Incorporated
Decision Date2020-06-02
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism is a medical device manufactured by Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2020-06-02 under approval number K200528. 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 Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism?

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism is a medical device that received FDA 510(k) clearance on 2020-06-02. It is manufactured by Bausch + Lomb, Incorporated. The 510(k) number is K200528.

When was Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism approved by the FDA?

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism received FDA 510(k) clearance on 2020-06-02, under approval number K200528.

What company makes Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism?

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism is manufactured by Bausch + Lomb, Incorporated.

What is the FDA product code for Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism?

The FDA product code for Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism is LPL.

Related Clinical Trials

NCT06873048 Short-term Study of Two Soft Contact Lenses in Wearers With Low Astigmatism COMPLETED NCT07303920 Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day RECRUITING

Other Devices by Bausch + Lomb, Incorporated

K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) K211786Independent Corneal Viewing Chamber (IVC-21) K230954Samfilcon B Custom Contact Lens

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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