FDA 510(k) Application Details - K221246

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

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510(K) Number K221246
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Semlamp Intelligent Technology Co., Ltd
Room 915, Lankun Building, Minkang Road 213,
Zhangkeng Community, Minzhi Avenue, Longhua
Shenzhen 518131 CN
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Contact Qi Wenjun
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 05/02/2022
Decision Date 07/07/2022
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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