510(k) clearance
PureLift Pro Max
- 510(k) number
- K262861
- Applicant
- Xtreem Pulse, LLC
- Decision date
- Sep 11, 2026
- Date received
- Aug 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- NFO
- Device type
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device class
- Class II
- Regulation
- 21 CFR 882.5890
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- New York, NY, US