FDA 510(k) Application Details - K103455

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K103455
Device Name	Powered Laser Surgical Instrument
Applicant	LUTRONIC CORPORATION 51 EVERETT DRIVE, UNIT A-50 PRINCETON JUNCTION, NJ 08550 US Other 510(k) Applications for this Company
Contact	JHUNG WON VOJIR 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	11/23/2010
Decision Date	04/28/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review