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. These are mostly handheld facial toning devices that run low-level current through the skin. The record doesn't describe PureLift's design beyond the name.
Class II, 21 CFR 882.5890, Neurology panel. It's a Special 510(k), so Xtreem Pulse was modifying a device it already had cleared.
The company filed from New York, New York. Review took 29 days (August 13 to September 11, 2026), about the turnaround a Special 510(k) is designed for.
Clearance details
- Applicant
- Xtreem Pulse, LLC
- Product code
- 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
Recent devices under product code NFO
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