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FDA 510(k) Application Details - K242595
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K242595
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Greatro Electronic Technology Co., Ltd
East Side, 4/F Building A1, Xu'xing'da Industrial Park
Shiyan Sub-district, Bao'an District
Shenzhen 518108 CN
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Contact
Xinhua Yue
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHT
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More FDA Info for this Product Code
Date Received
08/30/2024
Decision Date
11/07/2024
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
FDA Source Information for K242595
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