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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 K060305
Device Name HAIRMAX LASERCOMB
Applicant
LEXINGTON INTERNATIONAL, LLC
1700 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Applicant Contact EDWARD BASILE
Correspondent
LEXINGTON INTERNATIONAL, LLC
1700 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Correspondent Contact EDWARD BASILE
Regulation Number890.5500
Classification Product Code
OAP  
Date Received02/06/2006
Decision Date 01/18/2007
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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