Cleared Special

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

K223394 · Visionary Optics, LLC · Ophthalmic
Dec 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K223394 is an FDA 510(k) clearance for the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon 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 December 7, 2022, 29 days after receiving the submission on November 8, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K223394 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2022
Decision Date December 07, 2022
Days to Decision 29 days
Submission Type Special
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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