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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 K001179
Device Name SUPER NOVA, ACUBEAM
Applicant
Light Force Therapy, Inc.
17725 Cleese Ct.
Payton,  CO  80831
Applicant Contact KIM PETERSON
Correspondent
Light Force Therapy, Inc.
17725 Cleese Ct.
Payton,  CO  80831
Correspondent Contact KIM PETERSON
Regulation Number890.5500
Classification Product Code
ILY  
Date Received04/11/2000
Decision Date 10/27/2000
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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