FDA 510(k) Application Details - K053457

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K053457
Device Name	Powered Laser Surgical Instrument
Applicant	TRIMEDYNE, INC. 15091 BAKE PKWY. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	GLENN D YEIK Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2005
Decision Date	12/21/2005
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	Y
Expedited Review