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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 K110233
Device Name HAIRMAX LASERCOMB
Applicant
Lexington International, LLC
1400 Sixteenth St., NW
Suite 400
Washington,  DC  20036
Applicant Contact CASPER E ULDRIKS ESQ.
Correspondent
Lexington International, LLC
1400 Sixteenth St., NW
Suite 400
Washington,  DC  20036
Correspondent Contact CASPER E ULDRIKS ESQ.
Regulation Number890.5500
Classification Product Code
OAP  
Date Received01/26/2011
Decision Date 05/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Type Traditional
Clinical Trials NCT00981461
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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