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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Power Electrosurgical Devices For Skin Lesion Destruction
510(k) Number K220493
Device Name Plaxpot Multi Plasma
Applicant
GCS Co. Limited
#1008, 555, Dunchon-daero, Jungwon-gu, Seongnam-si,
Gyeonggi-do
Seongnam,  KR 13215
Applicant Contact Su Kyung Park
Correspondent
Compliance Insight
497 Circle Freeway Dr. Unit 230
West Chester,  OH  45246
Correspondent Contact Su Kyung Park
Regulation Number878.4400
Classification Product Code
QVJ  
Date Received02/22/2022
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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