FDA 510(k) Application Details - K091125

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K091125
Device Name	Powered Light Based Non-Laser Surgical Instrument
Applicant	VERILUX 391 BRIDGE POINT DR. SOUTH ST. PAUL, MN 55075 US Other 510(k) Applications for this Company
Contact	RYAN DOUGLAS Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2009
Decision Date	09/03/2010
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