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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 K243097
Device Name RM STAR EX with RMS Needle
Applicant
Bomtech Electronics Co., Ltd.
322, Gonghang-Daero, Gangseo-Gu
Seoul,  KR
Applicant Contact Lee Junseok
Correspondent
Corazon
20, Jukjeon-Ro, Giheung-Gu, Gyeonggi-Do
Yongin,  KR 16897
Correspondent Contact Seo Juntaek
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/30/2024
Decision Date 12/26/2024
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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