FDA 510(k) Application Details - K243362

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K243362
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	CyDen Limited Block A, Bay Studios Business Park, Fabian Way, SA1 8QB Swansea GB Other 510(k) Applications for this Company
Contact	Adam Stephens 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	10/29/2024
Decision Date	11/27/2024
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