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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 K251566
Device Name TS-RF Generator (STS10)
Applicant
Starmed Co., Ltd.
B-Dong, 4f&12f, 158, Haneulmaeul-Ro. Ilsandong-Gu
Goyang-Si,  KR 10355
Applicant Contact Honggeun Lee
Correspondent
Bt Solutions, Inc.
Unit 303, Gonghang-Daero 337, Gangseo-Gu
Seoul,  KR 07590
Correspondent Contact Do Hyun Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/22/2025
Decision Date 11/17/2025
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
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