510(k) K233922

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG by Satelec - Acteon Group — Product Code ELC

K233922 is an FDA 510(k) premarket notification submitted by Satelec - Acteon Group for the device "SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG". The FDA issued a decision of Substantially Equivalent on March 11, 2024. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Satelec - Acteon Group has at least 10 other 510(k) clearances on record.