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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 K150466
Device Name ZX2 Laser System
Applicant
LZR7, Inc
1980 Broadway
Placerville,  CA  95667
Applicant Contact Randy Rinkleib
Correspondent
TEXAS APPLIED BIOMEDICAL SERVICES
12101 CULLEN BLVD. SUITE A
HOUSTON,  TX  77047
Correspondent Contact Joyce Heinrich
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/23/2015
Decision Date 06/08/2015
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
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