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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 K253859
Device Name Scarlet Pro (Scarlet Pro)
Applicant
VIOL Co., Ltd.
C-209-1, 502, 503-1, 503-2, 608, 609, 808, 809 Bundang
Technopark C, 744, Pangyo-Ro, Bundang-Gu, Seongnam-Si
Gyeonggi-Do,  KR 13510
Applicant Contact Hyein Yang
Correspondent
GMSC Co., Ltd.
B 612, 66, Cheongcho-Ro, Deokyang-Gu, Goyang-Si
Gyeonggi-Do,  KR 10543
Correspondent Contact Jonghyeon Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/03/2025
Decision Date 08/27/2026
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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