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FDA 510(k)

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

K-Number: K162223 · 2017-01-04

ApplicantSupervision Optimax Sdn Bhd
Decision Date2017-01-04
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is a medical device manufactured by Supervision Optimax Sdn Bhd. It received FDA 510(k) clearance on 2017-01-04 under approval number K162223. 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 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by Supervision Optimax Sdn Bhd. The 510(k) number is K162223.

When was Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) approved by the FDA?

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) received FDA 510(k) clearance on 2017-01-04, under approval number K162223.

What company makes Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is manufactured by Supervision Optimax Sdn Bhd.

What is the FDA product code for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

The FDA product code for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is LPL.

Other Devices by Supervision Optimax Sdn Bhd

K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses

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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