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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 K152019
Device Name HairMD
Applicant
TROPHY SKIN, INC.
4372 KENMORE TRAIL
FRISCO,  TX  75034
Applicant Contact IMRAN KARIM
Correspondent
NST CONSULTING, INC.
641 SHUNPIKE ROAD, SUITE 311
CHATHAM,  NJ  07928
Correspondent Contact RAYMOND R. BLANCHE
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/21/2015
Decision Date 11/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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