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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K160312
Device Name FRAXIS DUO
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 Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
GEI   OUH  
Date Received02/05/2016
Decision Date 10/28/2016
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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