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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 K081166
Device Name LIGHTSTREAM LOW LEVEL LASER
Applicant
Solica Corporation
129 Yorkville Ave.
Suite 300
Toronto, Ontario,  CA M5R 1C4
Applicant Contact CARLA WINSLOW
Correspondent
Solica Corporation
129 Yorkville Ave.
Suite 300
Toronto, Ontario,  CA M5R 1C4
Correspondent Contact CARLA WINSLOW
Regulation Number890.5500
Classification Product Code
NHN  
Date Received04/24/2008
Decision Date 04/03/2009
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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