Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)— 510(k) K171950

Name: FDA 510(k) clearance K171950
Creator: U.S. Food and Drug Administration
Published: 2017-08-16

Substantially Equivalent

Visionary Optics, LLC

FDA 510(k) clearance K171950 for Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B), Substantially Equivalent on 2017-08-16. Applicant: Visionary Optics, LLC. Device class: 2.

Clearance details

Applicant: Visionary Optics, LLC
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2017-06-29
Decision date: 2017-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Front Royal, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.