510(k) K262861

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

K262861 is an FDA 510(k) premarket notification submitted by Xtreem Pulse, LLC for the device "PureLift Pro Max". The FDA issued a decision of Substantially Equivalent on September 11, 2026. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2026
Date Received
August 13, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type