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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 K251327
Device Name XERF
Applicant
Lutronic Corporation
Lutronic Center
219, Sowon- Ro
Deogyang-Gu,  KR 410220
Applicant Contact Cynthia Aguirre
Correspondent
Lutronic Corporation
Lutronic Center
219, Sowon- Ro
Deogyang-Gu,  KR 410220
Correspondent Contact Cynthia Aguirre
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/30/2025
Decision Date 08/11/2025
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
Recalls CDRH Recalls
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