Cleared Traditional

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism

K240918 · Bruno Vision Care, LLC · Ophthalmic
Oct 2024
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K240918 is an FDA 510(k) clearance for the Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism, 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 October 25, 2024, 205 days after receiving the submission on April 3, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K240918 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2024
Decision Date October 25, 2024
Days to Decision 205 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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