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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 K041262
Device Name DURALITE-GL
Applicant
Laser Scientific
115 Sundance Pkwy. #230b
Round Rock,  TX  78681
Applicant Contact JOHN CROWNOVER
Correspondent
Laser Scientific
115 Sundance Pkwy. #230b
Round Rock,  TX  78681
Correspondent Contact JOHN CROWNOVER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/11/2004
Decision Date 08/13/2004
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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