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510(k) K150409

VIVACE Electrosurgical System by Sung Hwan E&B Co.,Ltd — Product Code OUH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 15, 2016
Date Received: February 18, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Skin Resurfacing Rf Applicator
Device Class: Class II
Regulation Number: 878.4400
Review Panel: SU
Submission Type

Skin resurfacing