510(k) K251909

NeurotriS (SX2500); NeurotriS (SX3800) by A-1 Engineering — Product Code NFO

K251909 is an FDA 510(k) premarket notification submitted by A-1 Engineering for the device "NeurotriS (SX2500); NeurotriS (SX3800)". The FDA issued a decision of Substantially Equivalent on September 3, 2025. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. A-1 Engineering has at least 1 other 510(k) clearance on record.