FDA 510(k) Application Details - K142573

Device Classification Name Laser, Comb, Hair

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510(K) Number K142573
Device Name Laser, Comb, Hair
Applicant LEXINGTON INTERNATIONAL, LLC
777 YAMATO RD SUITE 105
BOCA RATON, FL 33431 US
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Contact DAVID MICHAELS
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 09/12/2014
Decision Date 12/01/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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