510(k) K231562

ELEC ENGINE (Model: ISE-170L) by Micro-Nx Co., Ltd. — Product Code EBW

K231562 is an FDA 510(k) premarket notification submitted by Micro-Nx Co., Ltd. for the device "ELEC ENGINE (Model: ISE-170L)". The FDA issued a decision of Substantially Equivalent on July 18, 2025. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Micro-Nx Co., Ltd. has at least 6 other 510(k) clearances on record.