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FDA 510(k)

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

K-Number: K161739 · 2016-12-19

ApplicantPegavision Corporation
Decision Date2016-12-19
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses is a medical device manufactured by Pegavision Corporation. It received FDA 510(k) clearance on 2016-12-19 under approval number K161739. 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 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses?

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses is a medical device that received FDA 510(k) clearance on 2016-12-19. It is manufactured by Pegavision Corporation. The 510(k) number is K161739.

When was Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses approved by the FDA?

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses received FDA 510(k) clearance on 2016-12-19, under approval number K161739.

What company makes Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses?

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses is manufactured by Pegavision Corporation.

What is the FDA product code for Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses?

The FDA product code for Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses is LPL.

Related Clinical Trials

NCT06864858 Clinical Evaluation of Two Cosmetic Contact Lenses COMPLETED NCT06651996 Mobile-Based Telerehabilitation With Sensors for Adherence and Efficacy in Chronic Patellofemoral Pain: A Randomized Controlled Trial COMPLETED NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT07566234 Evaluation of Contact Lenses and Myopia. NOT_YET_RECRUITING NCT07600645 Contact Lens Trial Fitting Experience NOT_YET_RECRUITING NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED

Other Devices by Pegavision Corporation

K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

View all 9 devices →

Related Devices (Code: LPL)

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. K161124EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily WearVision Science Co., 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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