FDA 510(k) Application Details - K132518

Device Classification Name Light Based Over-The-Counter Hair Removal

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510(K) Number K132518
Device Name Light Based Over-The-Counter Hair Removal
Applicant WELLQUEST INTL., INC.
816 CONGRESS AVE, STE 1400
AUSTIN, TX 78701 US
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Contact ROBERT SEIPLE, RAC
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 08/12/2013
Decision Date 08/17/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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