FDA 510(k)

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

K-Number: K213119 · 2022-05-13

Decision Date2022-05-13

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Innova Vision, Inc.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K213119. 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 (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Innova Vision, Inc.. The 510(k) number is K213119.

When did Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2022-05-13, under 510(k) number K213119.

Who is the listed applicant for Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

The FDA 510(k) record lists Innova Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETED NCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETED NCT06751225Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With AstigmatismCOMPLETED NCT06995781Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)COMPLETED NCT07747311Contact Lenses to Slow Myopia Progression in AdultsNOT_YET_RECRUITING NCT04080128Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia ControlCOMPLETED

Other records listing Innova Vision, Inc. as applicant

K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

Related Devices (Code: LPL)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.