Cleared Traditional

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

K251095 · Pegavision Corporation · Ophthalmic
Sep 2025
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K251095 is an FDA 510(k) clearance for the Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Pegavision Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on September 17, 2025, 160 days after receiving the submission on April 10, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K251095 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2025
Decision Date September 17, 2025
Days to Decision 160 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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