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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 K222260
Device Name Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
Applicant
Capenergy Medical S.L.
Avinguda Mare De Déu De Montserrat, 41
Sant Joan Despi, Barcelona,  ES 08970
Applicant Contact Pilar Sanchez
Correspondent
Capenergy Medical S.L.
Avinguda Mare De Déu De Montserrat, 41
Sant Joan Despi, Barcelona,  ES 08970
Correspondent Contact Pilar Sanchez
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received07/28/2022
Decision Date 03/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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