FDA 510(k) Application Details - K100610

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K100610
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	LUTRONIC CORPORATION 5 TIMBER LANE NORTH READING, MA 01864 US Other 510(k) Applications for this Company
Contact	MAUREEN O'CONNELL Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2010
Decision Date	01/20/2011
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