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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 K143666
Device Name Noblex Long Pulse Alexandrite Laser
Applicant
Finemec Co., Ltd.
#230,7, Galhyeon-Ro 11gil, Eunpyeong-Gu
Seoul,  KR 122-902
Applicant Contact GHUN HEE LEE
Correspondent
Lsk Biopartners, Inc.
8 E. Broadway, Suite 611
Salt Lake City,  UT  84111
Correspondent Contact SHIN KUK YOO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/23/2014
Decision Date 04/23/2015
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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