510(k) K233325

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

K233325 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, fluoroxyfocon A)". The FDA issued a decision of Substantially Equivalent on February 21, 2024. 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.