FDA 510(k) Application Details - K190366

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K190366
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	CyDen Limited Block A, Bay Studios Business Park, Fabian Way Swansea SA1 8QB 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	02/15/2019
Decision Date	03/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review