FDA 510(k) Application Details - K142845

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

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510(K) Number K142845
Device Name Light Based Over-The-Counter Hair Removal
Applicant Wuhan Lotuxs Technology Co., Ltd
No. 666 High-tec Ave. East Lake High-tech Development Zone
R&D Building B1 of B, C, D Block, Wuhan National Biological
Wuhan 430075 CN
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Contact Wu Na
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 09/30/2014
Decision Date 07/01/2015
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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