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FDA 510(k) Application Details - K210376
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K210376
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Guangzhou Haoxingwan Technology Co., Ltd.
Room 718, No.9, Linhe West Road, Tianhe District
Guangzhou 510000 CN
Other 510(k) Applications for this Company
Contact
Chun Tao
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
OHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/09/2021
Decision Date
10/07/2021
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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