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FDA 510(k)

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens

K-Number: K180819 · 2018-05-16

ApplicantMenicon Co, Ltd.
Decision Date2018-05-16
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is a medical device manufactured by Menicon Co, Ltd.. It received FDA 510(k) clearance on 2018-05-16 under approval number K180819. 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 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens?

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2018-05-16. It is manufactured by Menicon Co, Ltd.. The 510(k) number is K180819.

When was One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens approved by the FDA?

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens received FDA 510(k) clearance on 2018-05-16, under approval number K180819.

What company makes One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens?

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is manufactured by Menicon Co, Ltd..

What is the FDA product code for One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens?

The FDA product code for One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is LPL.

Related Clinical Trials

NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes 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

Other Devices by Menicon Co, Ltd.

K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses K180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens K193399Miru 1day UpSide (midafilcon A) K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution PMA P990018Lens, contact, orthokeratology, overnight

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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