FDA 510(k) Application Details - K250065

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K250065
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Jeisys Medical Incorporated 307 Daeryung Techno Town 8th, Gamasan-ro 96, Geumcheon-Gu Seoul 08501 KR Other 510(k) Applications for this Company
Contact	Jeongwook Lee Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2025
Decision Date	07/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review