Cleared Traditional

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

K233325 · Visionary Optics, LLC · Ophthalmic
Feb 2024
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K233325 is an FDA 510(k) clearance for the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A), a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Visionary Optics, LLC (Front Royal, US). The FDA issued a Cleared decision on February 21, 2024, 145 days after receiving the submission on September 29, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K233325 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date February 21, 2024
Days to Decision 145 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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