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FDA 510(k) Application Details - K203510
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K203510
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Weikai Technology CO.,LTD
FL402, Building A, No.466 Jinbi Road, Biling Community,
Biling Street, Pingshan District
Shenzhen 518118 CN
Other 510(k) Applications for this Company
Contact
Jing Li
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
11/30/2020
Decision Date
02/26/2021
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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