510(k) K234061

StarFormer by Fotona D.O.O. — Product Code KPI

K234061 is an FDA 510(k) premarket notification submitted by Fotona D.O.O. for the device "StarFormer". The FDA issued a decision of Substantially Equivalent on July 1, 2024. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Fotona D.O.O. has at least 10 other 510(k) clearances on record.