FDA 510(k) Application Details - K091568

Device Classification Name	Light, Ultraviolet, Dermatological   More FDA Info for this Device
510(K) Number	K091568
Device Name	Light, Ultraviolet, Dermatological
Applicant	LERNER MEDICAL DEVICES, INC. 1545 SAWTELLE BLVD., SUITE 36 LOS ANGELES, CA 90025 US Other 510(k) Applications for this Company
Contact	ZAFIRIOS F GOURGOULIATOS Other 510(k) Applications for this Contact
Regulation Number	878.4630   More FDA Info for this Regulation Number
Classification Product Code	FTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2009
Decision Date	11/05/2009
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