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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 K093499
Device Name HAIRMAX LASERCOMB
Applicant
Lexington International, LLC
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact CHERITA JAMES
Correspondent
Lexington International, LLC
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact CHERITA JAMES
Regulation Number890.5500
Classification Product Code
OAP  
Subsequent Product Code
GEX  
Date Received11/12/2009
Decision Date 11/23/2009
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
Predetermined Change
Control Plan Authorized		 No
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