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FDA 510(k)

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens

K-Number: K251573 · 2025-09-10

ApplicantVizionfocus, Inc.
Decision Date2025-09-10
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is a medical device manufactured by Vizionfocus, Inc.. It received FDA 510(k) clearance on 2025-09-10 under approval number K251573. 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 VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens?

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2025-09-10. It is manufactured by Vizionfocus, Inc.. The 510(k) number is K251573.

When was VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens approved by the FDA?

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2025-09-10, under approval number K251573.

What company makes VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens?

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is manufactured by Vizionfocus, Inc..

What is the FDA product code for VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens?

The FDA product code for VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is LPL.

Related Clinical Trials

NCT07588672 Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis NOT_YET_RECRUITING NCT06778057 Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses COMPLETED

Other Devices by Vizionfocus, Inc.

K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)

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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