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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, comb, hair
510(k) Number K121920
Model LHB 7, LHB 9, LHB 12
Device Name LASERBRUSH
Original Applicant
SUNETICS INTERNATIONAL MARKETING GROUP, LLC
892 steger towne rd #44
rockwall,  TX  75032
Original Contact john carullo
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/02/2012
Decision Date 06/27/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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