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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 K170325
Device Name SECRET RF
Applicant
Ilooda Co,., Ltd.
120, Jangan-Ro 458 Beon-Gil
Jangan-Gu
Suwon-Si,  KR 100-85816200
Applicant Contact Yun Jung Ha
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OUH  
Date Received02/02/2017
Decision Date 06/13/2017
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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