Cleared Traditional

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)

K251683 · Bruno Vision Care, LLC · Ophthalmic
Dec 2025
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K251683 is an FDA 510(k) clearance for the Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Bruno Vision Care, LLC (Boca Raton, US). The FDA issued a Cleared decision on December 23, 2025, 207 days after receiving the submission on May 30, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K251683 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date December 23, 2025
Days to Decision 207 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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