PureLift Pro Max— 510(k) K262861
Substantially EquivalentXtreem Pulse, LLC
FDA 510(k) clearance K262861 for PureLift Pro Max, Substantially Equivalent on 2026-09-11. Applicant: Xtreem Pulse, LLC. Device class: 2.
Summary
PureLift Pro Max is filed under NFO, transcutaneous electrical stimulators for aesthetic purposes. The record doesn't describe PureLift's design beyond the name.
Class II, 21 CFR 882.5890. The Neurology panel reviewed it as a Special 510(k).
Xtreem Pulse filed from New York, New York. Review took 29 days (August 13 to September 11, 2026).
Clearance details
- Applicant
- Xtreem Pulse, LLC
- Product code
- Product code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- New York, NY, US
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