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510(k) K112334

VEIN-GOGH INSTRUMENT by Refine USA, LLC — Product Code ONQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 8, 2012
Date Received: August 12, 2011
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.