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FDA 510(k)

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

K-Number: K222954 · 2023-03-13

ApplicantInnova Vision, Inc.
Decision Date2023-03-13
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is a medical device manufactured by Innova Vision, Inc.. It received FDA 510(k) clearance on 2023-03-13 under approval number K222954. 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 Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens?

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2023-03-13. It is manufactured by Innova Vision, Inc.. The 510(k) number is K222954.

When was Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens approved by the FDA?

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2023-03-13, under approval number K222954.

What company makes Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens?

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is manufactured by Innova Vision, Inc..

What is the FDA product code for Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens?

The FDA product code for Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is LPL.

Related Clinical Trials

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Other Devices by Innova Vision, Inc.

K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens

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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