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FDA 510(k)

Samfilcon B Custom Contact Lens

K-Number: K230954 · 2023-11-17

ApplicantBausch + Lomb, Incorporated
Decision Date2023-11-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Samfilcon B Custom Contact Lens is a medical device manufactured by Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2023-11-17 under approval number K230954. 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 Samfilcon B Custom Contact Lens?

Samfilcon B Custom Contact Lens is a medical device that received FDA 510(k) clearance on 2023-11-17. It is manufactured by Bausch + Lomb, Incorporated. The 510(k) number is K230954.

When was Samfilcon B Custom Contact Lens approved by the FDA?

Samfilcon B Custom Contact Lens received FDA 510(k) clearance on 2023-11-17, under approval number K230954.

What company makes Samfilcon B Custom Contact Lens?

Samfilcon B Custom Contact Lens is manufactured by Bausch + Lomb, Incorporated.

What is the FDA product code for Samfilcon B Custom Contact Lens?

The FDA product code for Samfilcon B Custom Contact Lens is LPL.

Related Clinical Trials

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

Other Devices by Bausch + Lomb, Incorporated

K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism K211786Independent Corneal Viewing Chamber (IVC-21)

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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