Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K251095): 510(k) cleared Sep 17, 2025

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

Pegavision Corporation · Sep 17, 2025 · K251095

FDA cleared the Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses from Pegavision Corporation on Sep 17, 2025 under K251095, a traditional 510(k). The device falls under product code LPL, Lenses, Soft Contact, Daily Wear, regulated at 21 CFR 886.5925 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Apr 10, 2025. The decision came 160 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Pegavision Corporation has 3 other decisions in the tracker over the last 12 months: K253352 (Pegavision (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 Lenses), K261299 (Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses), K252385 (Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses).

Questions & Answers

What did FDA clear under K251095?

K251095 is the FDA 510(k) for Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses, submitted by Pegavision Corporation. FDA's decision date was Sep 17, 2025, under product code LPL (Lenses, Soft Contact, Daily Wear).

Who makes the Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses?

Pegavision Corporation, based in Taoyuan City, is the applicant of record for K251095.

How long did the K251095 review take?

FDA received the submission on Apr 10, 2025 and issued its decision on Sep 17, 2025, 160 days later.

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