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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K243223
Device Name Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
Applicant
Bh Group Us, LLC
10380 W. Sr 84 #7
Davie,  FL  33324
Applicant Contact Diego Bazzurro
Correspondent
Bh Group Us, LLC
10380 W. Sr 84 #7
Davie,  FL  33324
Correspondent Contact Diego Bazzurro
Regulation Number878.4400
Classification Product Code
PBX  
Date Received10/07/2024
Decision Date 09/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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