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FDA 510(k)

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

K-Number: K230824 · 2023-09-06

ApplicantArt Optical Contact Lens, Inc.
Decision Date2023-09-06
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is a medical device manufactured by Art Optical Contact Lens, Inc.. It received FDA 510(k) clearance on 2023-09-06 under approval number K230824. 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 IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is a medical device that received FDA 510(k) clearance on 2023-09-06. It is manufactured by Art Optical Contact Lens, Inc.. The 510(k) number is K230824.

When was IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) approved by the FDA?

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) received FDA 510(k) clearance on 2023-09-06, under approval number K230824.

What company makes IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is manufactured by Art Optical Contact Lens, Inc..

What is the FDA product code for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

The FDA product code for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) 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 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 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 NCT07223086 Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity RECRUITING

Other Devices by Art Optical Contact Lens, Inc.

K172314Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

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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