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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 K142824
Device Name LX-100 Hair Growth Stimulation System
Applicant
Hairlabs International Inc
742 Harpeth Knoll Road
Nashville,  TN  37221
Applicant Contact James Britt
Correspondent
Hairlabs International Inc
742 Harpeth Knoll Road
Nashville,  TN  37221
Correspondent Contact James Britt
Regulation Number890.5500
Classification Product Code
OAP  
Subsequent Product Code
NHN  
Date Received09/30/2014
Decision Date 04/14/2015
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
Predetermined Change
Control Plan Authorized		 No
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