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FDA 510(k)

Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac

K-Number: K182734 · 2019-05-16

ApplicantUnicon Optical Co., Ltd.
Decision Date2019-05-16
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac is a medical device manufactured by Unicon Optical Co., Ltd.. It received FDA 510(k) clearance on 2019-05-16 under approval number K182734. 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 with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac?

Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac is a medical device that received FDA 510(k) clearance on 2019-05-16. It is manufactured by Unicon Optical Co., Ltd.. The 510(k) number is K182734.

When was Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac approved by the FDA?

Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac received FDA 510(k) clearance on 2019-05-16, under approval number K182734.

What company makes Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac?

Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac is manufactured by Unicon Optical Co., Ltd..

What is the FDA product code for Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac?

The FDA product code for Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac is LPL.

Related Clinical Trials

NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED NCT07076160 Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses COMPLETED NCT06967129 Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process COMPLETED NCT07223086 Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity RECRUITING NCT06778057 Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses COMPLETED NCT07364435 Effect of Bed Bathing Methods on VRE Colonization in ICU Patients COMPLETED

Other Devices by Unicon Optical Co., Ltd.

K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens 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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