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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K231216
Device Name POTENZA
Applicant
Jeisys Medical, Inc.
307 Daeryung Techno Town 8th
Seoul,  KR 08501
Applicant Contact Bora Kim
Correspondent
E & M
D-1474, 230, Simin-Daero, Dongan-Gu
Anyang-Si,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/28/2023
Decision Date 12/10/2024
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
Predetermined Change
Control Plan Authorized		 No
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