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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K252704
Device Name F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
Applicant
F Care Systems USA, LLC
755 NE 164th Terrace
Miami,  FL  33162
Applicant Contact Danciu Patrick
Correspondent
F Care Systems NV
Uitbreidingstraat 42-46
Berchem,  BE 2600
Correspondent Contact Steven Mertens
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
ONQ  
Date Received08/27/2025
Decision Date 11/24/2025
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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