FDA 510(k) Application Details - K242382

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K242382
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	ISMART Developments Ltd 129 Green Lanes Wylde Green 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	08/12/2024
Decision Date	11/08/2024
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