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510(k) K243587

PureLift GLOW by Xtreem Pulse, LLC — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2025
Date Received
November 20, 2024
Clearance Type
Traditional
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

Other clearances by Xtreem Pulse, LLC

  • K230506 — PureLift Pro Edition (June 21, 2023)
  • K221443 — PureLift Pro Plus (October 21, 2022)
  • K190269 — PureLift (August 28, 2019)
  • K173483 — Pure Flow External Counter-Pulsation Device (May 30, 2018)

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