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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 K253165
Device Name LAP-iX2N
Applicant
Sejong Medical Co., Ltd.
11 Sinchon 2-Ro, Paju-Si
Gyeonggi-Do,  KR 10880
Applicant Contact Jinho Kim
Correspondent
Sejong Medical Co., Ltd.
11 Sinchon 2-Ro, Paju-Si
Gyeonggi-Do,  KR 10880
Correspondent Contact Jinho Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/26/2025
Decision Date 06/09/2026
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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