FDA 510(k) Application Details - K231555

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K231555
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	iSMART Developments Ltd 129 Green Lanes, Boldmere, Sutton Coldfield Birmingham B73 5LT GB Other 510(k) Applications for this Company
Contact	Susan D'Arcy 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	05/30/2023
Decision Date	07/27/2023
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