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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 K161198
Device Name Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
Applicant
USA LASER BIOTECH INC.
9210 FOREST HILL AVENUE
SUITE B-3
RICHMOND,  VA  23235
Applicant Contact NELSON MARQUINA
Correspondent
TEXAS APPLIED BIOMEDICAL SERVICES, INC.
1201 CULLEN BOULEVARD
#A
HOUSTON,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received04/28/2016
Decision Date 07/26/2016
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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