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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 K230412
Device Name Symmed Elite Aesthetic
Calle Ataulfo Friera Tarfe, 8-33211
Gijon,  ES
Applicant Contact Cristina Cifuentes Pantoja
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Aubrey Thompson
Regulation Number878.4400
Classification Product Code
Date Received02/15/2023
Decision Date 04/13/2023
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