FDA 510(k) Application Details - K111359

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K111359
Device Name	Powered Laser Surgical Instrument
Applicant	SHEAUMANN LASERS 189 WINDING OAKS LANE OVIEDO, FL 32765 US Other 510(k) Applications for this Company
Contact	TIMOTHY J SHEA 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	05/16/2011
Decision Date	09/13/2011
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