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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 K254185
Device Name Potenza Prime
Applicant
Jeisys Medical Incorporated
307 Daeryung Techno Town 8th
Gamasan-Ro 96, Geumcheon-Gu
Seoul,  KR 08501
Applicant Contact HeeKyung Kim
Correspondent
Hoy & Associates Regulatory Consulting, LLC
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Connie Hoy
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OUH  
Date Received12/23/2025
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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