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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 K080697
Device Name SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
Applicant
Global USA Distribution, LLC
9220 James Ave. S.
Bloomington,  MN  55431
Applicant Contact RONALD BERGLUND
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/12/2008
Decision Date 04/07/2008
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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