Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens

K-Number: K160803 · 2016-07-13

ApplicantCooperVision, Inc.
Decision Date2016-07-13
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens is a medical device manufactured by CooperVision, Inc.. It received FDA 510(k) clearance on 2016-07-13 under approval number K160803. 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 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens?

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2016-07-13. It is manufactured by CooperVision, Inc.. The 510(k) number is K160803.

When was Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens approved by the FDA?

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens received FDA 510(k) clearance on 2016-07-13, under approval number K160803.

What company makes Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens?

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens is manufactured by CooperVision, Inc..

What is the FDA product code for Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens?

The FDA product code for Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens is LPL.

Other Devices by CooperVision, Inc.

K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker K190965MyDay K202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC K213164Avaira Vitality K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens

View all 15 devices →

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.

↑