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FDA 510(k) Application Details - K220248
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K220248
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Mareal Tech Co., Ltd
301,Building 1,No.2,Xiashiwei Road,Huaide Community,
Fuyong Street, Baoan District
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Liu Libin
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
01/31/2022
Decision Date
07/01/2022
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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