FDA 510(k) Application Details - K211185

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

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510(K) Number K211185
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Beauty Every Moment intelligent electric Co., Ltd.
Rm. 501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang
Avenue No. 164, Heping Community
Shenzhen 518100 CN
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Contact Luo Huajun
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 04/20/2021
Decision Date 12/20/2021
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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