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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 K151521
Device Name Phoenix Thera-Lase System
Applicant
Phoenix Thera-Lase Systems, LLC
5454 La Sierra Dr., Suite 203
Dallas,  TX  75231
Applicant Contact GARY BELLINGER
Correspondent
Ken Block Consulting
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/05/2015
Decision Date 09/04/2015
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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