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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 K010175
Device Name MICROLIGHT 830 LASER SYSTEM
Applicant
Microlight Corporation of America
2935 Highland Lakes
Missouri City,  TX  77459
Applicant Contact MICHAEL BARBOUR
Correspondent
Microlight Corporation of America
2935 Highland Lakes
Missouri City,  TX  77459
Correspondent Contact MICHAEL BARBOUR
Regulation Number890.5500
Classification Product Code
NHN  
Date Received01/18/2001
Decision Date 02/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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