FDA 510(k) Application Details - K183217

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

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510(K) Number K183217
Device Name Light Based Over-The-Counter Hair Removal
Applicant Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
7/F, Marina Bay Centre A, South of Xinhua Road
BaoÆan District
Shenzhen CN
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Contact Aaron Zhai
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 11/19/2018
Decision Date 02/15/2019
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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