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FDA 510(k)

Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens

K-Number: K232139 · 2023-11-16

ApplicantInnova Vision, Inc.
Decision Date2023-11-16
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Innova Vision (inifilcon A) Silicone Hydrogel 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 2023-11-16 under 510(k) number K232139. 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 (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens?

Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Innova Vision, Inc.. The 510(k) number is K232139.

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

Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2023-11-16, under 510(k) number K232139.

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

The FDA product code for Innova Vision (inifilcon A) Silicone Hydrogel 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.

NCT06995781Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)COMPLETEDNCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETEDNCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETEDNCT06751225Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With AstigmatismCOMPLETEDNCT06778057Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact LensesCOMPLETEDNCT07747311Contact Lenses to Slow Myopia Progression in AdultsNOT_YET_RECRUITING

Other records listing Innova Vision, Inc. as applicant

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.

K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensK222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensK213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Related Devices (Code: LPL)

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.

K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision Corporation

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.

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