FDA 510(k) Application Details - K130195

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K130195
Device Name	Laser, Ophthalmic
Applicant	LUMENIS, INC. 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 US Other 510(k) Applications for this Company
Contact	JACE R MCLANE Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2013
Decision Date	11/01/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review