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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 K180945
Device Name LUTRONIC GENIUS Radiofrequency System
Applicant
Lutronic Corporation
Lutronic Center, 219, Sowon-Ro
Deogyang-Gu, Goyang-Si,  KR 410220
Applicant Contact Jhung Won Vojir
Correspondent
Lutronic Corporation
19 Fortune Dr.
Billerica,  MA  01821
Correspondent Contact James Childs
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/11/2018
Decision Date 12/10/2018
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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