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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 K110558
Device Name CS1000 LIGHT THERAPY DEVICE
Applicant
Genesis Health Light Corporation
7 Innovation Dr.
Suite 102
Hamilton, Ontario,  CA L9H 7H9
Applicant Contact PAUL ZIEMER
Correspondent
Genesis Health Light Corporation
7 Innovation Dr.
Suite 102
Hamilton, Ontario,  CA L9H 7H9
Correspondent Contact PAUL ZIEMER
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/28/2011
Decision Date 07/12/2012
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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