FDA 510(k), K150409, VIVACE Electrosurgical System

510(K) Number: K150409
Device Name: VIVACE Electrosurgical System
Manufacturer: Sung Hwan E&B Co.,Ltd
Device Classification Name: skin resurfacing rf applicator
Regulation Number: 878.4400
Classification Product Code: OUH
Date Received: 02/18/2015
Decision Date: 01/15/2016
Regulation Medical Specialty: General & Plastic Surgery

NOTE: 53 out of 99 pages fully redacted and most removed from the file.