Cleared Traditional

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

K222885 · Pegavision Corporation · Ophthalmic
May 2023
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K222885 is an FDA 510(k) clearance for the Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), 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 May 31, 2023, 250 days after receiving the submission on September 23, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K222885 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2022
Decision Date May 31, 2023
Days to Decision 250 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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