FDA 510(k) Application Details - K161428

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

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510(K) Number K161428
Device Name Light Based Over-The-Counter Hair Removal
Applicant SHEN ZHEN COSBEAUTY CO.,LTD.
UNIT A- 3F, QIAO DE INDUSTRIAL PARK, TIAN LIAO, GUANG MING
GUANG MING DISTRICT
Shenzhen 518000 CN
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Contact Nicole Hu
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 05/23/2016
Decision Date 03/23/2017
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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