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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 K112524
Device Name HAIRMAX LASERCOMB
Applicant
LEXINGTON INTERNATIONAL, LLC
777 YAMATO RD., SUITE 105
BOCA RATON,  FL  33431
Applicant Contact DAVID MICHAELS
Correspondent
LEXINGTON INTERNATIONAL, LLC
777 YAMATO RD., SUITE 105
BOCA RATON,  FL  33431
Correspondent Contact DAVID MICHAELS
Regulation Number890.5500
Classification Product Code
OAP  
Date Received08/31/2011
Decision Date 09/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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