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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 K241157
Device Name Secret MAX Multi-platform RF System
Applicant
Ilooda Co,., Ltd.
9f, 25, Deokcheon-Ro 152beon-Gil, Manan-Gu
Anyang-Si,  KR 14084
Applicant Contact Ha Yunjung
Correspondent
Bt Solutions, Inc.
Unit 904, Eonju-Ro 86-Gil 5 Gangnam-Gu
Seoul,  KR 06210
Correspondent Contact Kim Do Hyun
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
OUH   PBX  
Date Received04/26/2024
Decision Date 11/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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