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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 K252833
Device Name VIVA combo RF System
Applicant
Starmed Co., Ltd.
B-Dong, 4f,12f, 158, Haneulmaeul-Ro
Ilsandong-Gu
Goyang-Si,  KR 10355
Applicant Contact Lee Honggeun
Correspondent
MED Institute
1330 Win Hentschel Blvd., Suite 100
West Lafayette,  IN  47906
Correspondent Contact Daniel Dillon
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/05/2025
Decision Date 05/26/2026
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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