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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K243587
Device Name PureLift GLOW
Applicant
Xtreem Pulse, LLC
353 W. 29th St., Suite 3
New York,  NY  10001
Applicant Contact Andrew Barile
Correspondent
Xtreem Pulse, LLC
353 W. 29th St., Suite 3
New York,  NY  10001
Correspondent Contact Jacqueline Schmainda
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
OHS  
Date Received11/20/2024
Decision Date 03/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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