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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 K183538
Device Name VIVA combo RF System
Applicant
Starmed Co., Ltd.
B-Dong, 4f, 158, Haneulmaeul-Ro, Ilsandong-Gu
Goyang-Si,  KR 10355
Applicant Contact Jun-Young Jung
Correspondent
Starmed Co., Ltd.
B-Dong, 4f, 158, Haneulmaeul-Ro, Ilsandong-Gu
Goyang-Si,  KR 10355
Correspondent Contact Jun-Young Jung
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/19/2018
Decision Date 01/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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