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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K033986
Device Name MLT-1000 IR LASER SYSTEM
Applicant
Medical Laser Therapeutics LP
12101-A Cullen Blvd.
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Medical Laser Therapeutics LP
12101-A Cullen Blvd.
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/23/2003
Decision Date 03/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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