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FDA 510(k) Application Details - K221246
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Qi Wenjun
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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