FDA 510(k) Application Details - K111483

Device Classification Name	More FDA Info for this Device
510(K) Number	K111483
Device Name	JOULE CLEARSENSE LASER SYSTEM
Applicant	SCITON, INC. 925 COMMERCIAL ST. PALO ALTO, CA 94303 US Other 510(k) Applications for this Company
Contact	JAY M PATEL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2011
Decision Date	12/07/2011
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