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510(k) Data Aggregation
K Number
K171707Device Name
GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
Manufacturer
Gowoonsesang Cosmetics Co., Ltd
Date Cleared
2017-08-08
(61 days)
Product Code
GEI, THE
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Gowoonsesang Cosmetics Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use RF electrode (Needle Type) is a monopolar electrosurgical electrode indicated for coagulation of soft tissue when it used in conjunction with compatible radio frequency electrosurgical device.
Device Description
Single Use RF Electrode (Needle Type) consists of conductive electrode part, insulation coated part and conductive post part. There are several models (Models: GA-B, GA-C, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A) according to the total size and needle electrode part size. The conductive post of electrode is inserted into the head of the intended handpiece to receive the radio frequency current and delivers the current to a target tissue for coagulation in electrosurgical procedure. This device is a monopolar RF electrosurgical electrode used in conjunction with radio frequency electrosurgical device and a neutral electrode plate which complies with IEC 60601-1 and IEC 60601-2-2. It is intended to be used exclusively with the ESU cleared in K160469, Model: AGNES.
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K Number
K160469Device Name
AGNES
Manufacturer
GOWOONSESANG COSMETICS CO., LTD
Date Cleared
2017-01-05
(321 days)
Product Code
GEI, KCW, THE
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
GOWOONSESANG COSMETICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Device Description
AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable neutral electrode pad and a footswitch.
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