FDA 510(k) Application Details - K122280

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K122280
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	CYDEN LIMITED 2001 PENNSYLANIA AVE SUITE 950 WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	AUSTIN SPEIER 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	07/30/2012
Decision Date	10/23/2012
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