FDA 510(k) Application Details - K210077

Device Classification Name	Electrosurgical Coagulation For Aesthetic   More FDA Info for this Device
510(K) Number	K210077
Device Name	Electrosurgical Coagulation For Aesthetic
Applicant	F Care Systems USA LLC 11098 Biscayne BLVD Suite 301 Miami, FL 33161 US Other 510(k) Applications for this Company
Contact	Patrick Danciu Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	ONQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2021
Decision Date	12/17/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review