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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 K142573
Device Name HairMax LaserComb, HairMax LaserComb
Applicant
LEXINGTON INTERNATIONAL, LLC
777 YAMATO RD SUITE 105
BOCA RATON,  FL  33431
Applicant Contact DAVID MICHAELS
Correspondent
OLSSON FRANK WEEDA TERMAN MATZ PC
600 NEW HAMPHIRE AVENUE, NW SUITE 500
WASHINGTON DC,  DC  20037
Correspondent Contact EVAN P PHELPS
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/12/2014
Decision Date 12/01/2014
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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