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510(k) K083352

VEINWAVE, TC3000 by Newlands Clinical Trials, Ltd. — Product Code ONQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 12, 2009
Date Received: November 13, 2008
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.