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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 K083272
Device Name SKINCLEAR Q-SWITCHED ND:YAG LASER
Applicant
Global USA Distribution, LLC
10723 Aquila Av. S.
Minneapolis,  MN  55438
Applicant Contact MATT MAKOUSKY
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/06/2008
Decision Date 12/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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