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FDA 510(k)

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens

K-Number: K180004 · 2018-02-22

ApplicantMenicon Co, Ltd.
Decision Date2018-02-22
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a medical device manufactured by Menicon Co, Ltd.. It received FDA 510(k) clearance on 2018-02-22 under approval number K180004. 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 Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens?

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Menicon Co, Ltd.. The 510(k) number is K180004.

When was Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens approved by the FDA?

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens received FDA 510(k) clearance on 2018-02-22, under approval number K180004.

What company makes Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens?

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is manufactured by Menicon Co, Ltd..

What is the FDA product code for Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens?

The FDA product code for Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is LPL.

Related Clinical Trials

NCT07588672 Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis NOT_YET_RECRUITING NCT06778057 Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses COMPLETED

Other Devices by Menicon Co, Ltd.

K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses K180819One Day Flat Pack (hioxifilcon A) Daily Disposable 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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