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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K023935
Device Name TRILUMINA THERAPEUTIC LASER SYSTEM
Applicant
Texas Applied Biomedical Services
12101-A Cullen Blvd.
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Texas Applied Biomedical Services
12101-A Cullen Blvd.
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
NHN  
Date Received11/26/2002
Decision Date 01/28/2003
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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