FDA 510(k) Application Details - K081307

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K081307
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	PHOTO THERAPEUTICS, INC. 2720 LOKER AVENUE WEST CARLSBAD, CA 92010 US Other 510(k) Applications for this Company
Contact	SUE DARCY Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2008
Decision Date	01/16/2009
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