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FDA 510(k) Application Details - K241343
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K241343
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Lescolton Electrical Appliance Co., Ltd
Room 301, Building 04, No. A3, Fourth Industrial Zone
Heshuikou Community,
Shenzhen 518105 CN
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Contact
Zhikui Chen
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
05/13/2024
Decision Date
07/09/2024
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 K241343
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