FDA 510(k) Application Details - K081704

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K081704
Device Name	Powered Laser Surgical Instrument
Applicant	LUMENIS, INC. 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 US Other 510(k) Applications for this Company
Contact	TINA MAYER 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	06/17/2008
Decision Date	09/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review