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FDA 510(k) Application Details - K242700
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K242700
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
Shenzhen Nuon Medical Equipment Co., Ltd
1st Floor-3rd Floor, No. 27-2, Xintang Rd, Xintian Community
Fuhai Street, Baoan District
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Alain Dijkstra
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2024
Decision Date
12/19/2024
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 K242700
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