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510(k) K210077

MED RF 4000 by F Care Systems USA, LLC — Product Code ONQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 17, 2021
Date Received: January 12, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrosurgical Coagulation For Aesthetic
Device Class: Class II
Regulation Number: 878.4400
Review Panel: SU
Submission Type

For the treatment of spider vein or telangiectasia by thermocoagulation.