510(k) K223394

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) by Visionary Optics, LLC — Product Code HQD

K223394 is an FDA 510(k) premarket notification submitted by Visionary Optics, LLC for the device "Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)". The FDA issued a decision of Substantially Equivalent on December 7, 2022. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Visionary Optics, LLC has at least 2 other 510(k) clearances on record.