Cleared Traditional

Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)

K243953 · Vizionfocus, Inc. · Ophthalmic
Apr 2025
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K243953 is an FDA 510(k) clearance for the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Vizionfocus, Inc. (Miaoli County, TW). The FDA issued a Cleared decision on April 10, 2025, 108 days after receiving the submission on December 23, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K243953 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2024
Decision Date April 10, 2025
Days to Decision 108 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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