Cleared Traditional

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

K171950 · Visionary Optics, LLC · Ophthalmic
Aug 2017
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K171950 is an FDA 510(k) clearance for the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B), 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 August 16, 2017, 48 days after receiving the submission on June 29, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K171950 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2017
Decision Date August 16, 2017
Days to Decision 48 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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