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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 K230659
Device Name Zionic Aesthetic
Applicant
TermoSalud
Calle Ataulfo Friera Tarfe, 8-33211
Gijon,  ES
Applicant Contact Cristina Cifuentes Pantoja
Correspondent
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Aubrey Thompson
Regulation Number878.4400
Classification Product Code
PBX  
Date Received03/09/2023
Decision Date 06/08/2023
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
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