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FDA 510(k)

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

K-Number: K191929 · 2019-09-17

ApplicantUnicon Optical Co., Ltd.
Decision Date2019-09-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device manufactured by Unicon Optical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-17 under approval number K191929. 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 UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2019-09-17. It is manufactured by Unicon Optical Co., Ltd.. The 510(k) number is K191929.

When was UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens approved by the FDA?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2019-09-17, under approval number K191929.

What company makes UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is manufactured by Unicon Optical Co., Ltd..

What is the FDA product code for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

The FDA product code for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is LPL.

Related Clinical Trials

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Other Devices by Unicon Optical Co., Ltd.

K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™

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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