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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 K153399
Device Name LightStim Professional LED Bed
Applicant
LED Intellectual Properties LLC
16552 Von Karman Ave
irvine,  CA  92606
Applicant Contact steve marchese
Correspondent
LED Intellectual Properties LLC
16552 Von Karman Ave
irvine,  CA  92606
Correspondent Contact steve marchese
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/24/2015
Decision Date 07/05/2016
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
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