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FDA 510(k) Application Details - K222710
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K222710
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Siken 3D Technology Development Co., Ltd.
4th Building,No.33 Left East Avenue,Songgang,
Bao'an District
Shenzhen 518105 CN
Other 510(k) Applications for this Company
Contact
Jingquan Liu
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
09/08/2022
Decision Date
12/01/2022
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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