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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 K180885
Device Name HairMax Laser
Applicant
Lexington International, LLC
1040 Holland Drive
Boca Raton,  FL  33487
Applicant Contact David Michaels
Correspondent
NST Consulting, LLC
641 Shunpike Road, Suite 311
Chatham,  NJ  07928
Correspondent Contact Raymond R Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/04/2018
Decision Date 06/20/2018
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
Predetermined Change
Control Plan Authorized		 No
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