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FDA 510(k) Application Details - K222316
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K222316
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Goodwind Technology Development CO., LTD
4th&5Th Floor,2nd Part Of Building A1,
Yinlong Industrial Park, Gate 292, Longgang Section Of Sh
Shenzhen 518116 CN
Other 510(k) Applications for this Company
Contact
Ziming Yang
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
08/02/2022
Decision Date
09/28/2022
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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