510(k) K221443

PureLift Pro Plus by Xtreem Pulse, LLC — Product Code NFO

K221443 is an FDA 510(k) premarket notification submitted by Xtreem Pulse, LLC for the device "PureLift Pro Plus". The FDA issued a decision of Substantially Equivalent on October 21, 2022. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Xtreem Pulse, LLC has at least 5 other 510(k) clearances on record.