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FDA 510(k) Application Details - K161428
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K161428
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
SHEN ZHEN COSBEAUTY CO.,LTD.
UNIT A- 3F, QIAO DE INDUSTRIAL PARK, TIAN LIAO, GUANG MING
GUANG MING DISTRICT
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Nicole Hu
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
05/23/2016
Decision Date
03/23/2017
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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