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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 K160227
Device Name ACCENTO / HWA Dual/Single laser
Applicant
Bison Medical Co, Ltd.
Ace High-End Tower 6, 234 Beotkkot-Ro,
Geum Cheon Gu,  KR
Applicant Contact SUN WOO LEE
Correspondent
Bio-Med USA, Inc.
27 New England Dr.
Ramsey,  NJ  07446
Correspondent Contact YOUNG CHI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/29/2016
Decision Date 04/22/2016
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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