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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 K161981
Device Name Olive Plus
Applicant
AMA NETWORK INC
3600 WILSHIRE BLVD #1016
LOS ANGELES,  CA  90010
Applicant Contact YONG BAIK KIMM
Correspondent
BIO-MED USA INC.
27 NEW ENGLAND DRIVE
RAMSEY,  NJ  07446
Correspondent Contact YOUNG CHI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/19/2016
Decision Date 10/14/2016
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
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