Cleared Traditional

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens

K251573 · Vizionfocus, Inc. · Ophthalmic
Sep 2025
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K251573 is an FDA 510(k) clearance for the VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens, 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 September 10, 2025, 111 days after receiving the submission on May 22, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K251573 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2025
Decision Date September 10, 2025
Days to Decision 111 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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