Cleared Traditional

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

K252385 · Pegavision Corporation · Ophthalmic
Mar 2026
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K252385 is an FDA 510(k) clearance for the Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) 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 March 13, 2026, 225 days after receiving the submission on July 31, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K252385 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2025
Decision Date March 13, 2026
Days to Decision 225 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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