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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 K063574
Device Name LUMINEX LL LASER SYSTEM
Applicant
Medical Laser Systems, Inc.
800 Connecticut Ave. NW
Suite 500
Wahington,  DC  20006
Applicant Contact MIKI KOLTON
Correspondent
Medical Laser Systems, Inc.
800 Connecticut Ave. NW
Suite 500
Wahington,  DC  20006
Correspondent Contact MIKI KOLTON
Regulation Number890.5500
Classification Product Code
NHN  
Date Received11/29/2006
Decision Date 01/29/2007
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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