FDA 510(k) Application Details - K230473

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

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510(K) Number K230473
Device Name Light Based Over-The-Counter Hair Removal
Applicant Miley Technology(Hebei) Co., Ltd.
Building 3, High Tech Industrial Zone, South of Xinneng
Street, Economic Development Zone
Handan 057750 CN
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Contact Hualing Wang
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 02/22/2023
Decision Date 06/15/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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