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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 K232242
Device Name BEAR 2 Body
Applicant
Foreo, Inc.
1525 E Pama Lane
Las Vegas,  NV  89119
Applicant Contact Evan Feldstein
Correspondent
DD Consulting
4080 Living Arts Dr.
Mississauga,  CA L5B 4N3
Correspondent Contact Danijela Domljanovic
Regulation Number882.5890
Classification Product Code
NFO  
Date Received07/28/2023
Decision Date 05/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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