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FDA 510(k) Application Details - K241106
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K241106
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
ShenzhenáMlayáIntelligentáTechnologyáCo.,áLtd.
302,401,áBuildingá1,áNo.á2,áXiashiweiáRoad,áHuaideáCommunity
FuyongáStreet,áBaoanáDistrict
Shenzhen 518000 CN
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Contact
Libin Liu
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
04/22/2024
Decision Date
05/22/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241106
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