510(k) K242514

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) by Shenzhen Rogin Medical Co., Ltd. — Product Code EKX

K242514 is an FDA 510(k) premarket notification submitted by Shenzhen Rogin Medical Co., Ltd. for the device "Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)". The FDA issued a decision of Substantially Equivalent on April 24, 2025. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Shenzhen Rogin Medical Co., Ltd. has at least 1 other 510(k) clearance on record.