FDA 510(k)

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

K-Number: K213983 · 2022-09-02

Decision Date2022-09-02

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is a medical device manufactured by Yung Sheng Optical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-02 under approval number K213983. 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 Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear?

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by Yung Sheng Optical Co., Ltd.. The 510(k) number is K213983.

When was Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear approved by the FDA?

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear received FDA 510(k) clearance on 2022-09-02, under approval number K213983.

What company makes Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear?

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is manufactured by Yung Sheng Optical Co., Ltd..

What is the FDA product code for Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear?

The FDA product code for Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is LPL.

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Other Devices by Yung Sheng Optical Co., Ltd.

K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.