510(k) K232459

Velacur by Sonic Incytes — Product Code IYO

K232459 is an FDA 510(k) premarket notification submitted by Sonic Incytes for the device "Velacur". The FDA issued a decision of Substantially Equivalent on Sep 12, 2023. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Sonic Incytes has at least 3 other 510(k) clearances on record.