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510(k) Data Aggregation
K Number
K150409Device Name
VIVACE Electrosurgical System
Manufacturer
Sung Hwan E&B Co.,Ltd
Date Cleared
2016-01-15
(331 days)
Product Code
OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Sung Hwan E&B Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.
Device Description
The VIVACE Electrosurgical System is comprised of the following components: the system main body of the device which consists of the LCD touch screen control panel, the high frequency generating output section (main P.C.B board or RF Generator), and the power supply component, the Switching Power Supply (SMPS). The accessories to the device include the handpiece with disposable micro-need le cartridge (electrode) insertion, and foot switch. Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. The hand piece being held at right angles, the tip is placed in light contact with the epidermis. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator, hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be resterilized.
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