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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 K100474
Device Name QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
Applicant
Quicklase Limited
P.O. Box 1264,
1094 W. Greasewood Dr.
Riverton,  UT  84065
Applicant Contact CALVIN OSTLER
Correspondent
Quicklase Limited
P.O. Box 1264,
1094 W. Greasewood Dr.
Riverton,  UT  84065
Correspondent Contact CALVIN OSTLER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/18/2010
Decision Date 03/16/2010
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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