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FDA 510(k)

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

K-Number: K242855 · 2025-07-30

ApplicantE.O.S Co., Ltd.
Decision Date2025-07-30
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is a medical device manufactured by E.O.S Co., Ltd.. It received FDA 510(k) clearance on 2025-07-30 under approval number K242855. 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 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by E.O.S Co., Ltd.. The 510(k) number is K242855.

When was P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) approved by the FDA?

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) received FDA 510(k) clearance on 2025-07-30, under approval number K242855.

What company makes P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is manufactured by E.O.S Co., Ltd..

What is the FDA product code for P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

The FDA product code for P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is LPL.

Related Clinical Trials

NCT06864858 Clinical Evaluation of Two Cosmetic Contact Lenses COMPLETED NCT07566234 Evaluation of Contact Lenses and Myopia. NOT_YET_RECRUITING NCT07600645 Contact Lens Trial Fitting Experience NOT_YET_RECRUITING NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED NCT07586982 Clinical Performance of Verofilcon A Toric Contact Lenses RECRUITING NCT07076160 Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses COMPLETED

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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