FDA 510(k) Application Details - K094052

Device Classification Name	Ophthalmic Femtosecond Laser   More FDA Info for this Device
510(K) Number	K094052
Device Name	Ophthalmic Femtosecond Laser
Applicant	LENSX LASERS, INC. 733 BOLSANA DR. LAGUNA BEACH, CA 92651 US Other 510(k) Applications for this Company
Contact	Judy Gordon Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	OOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2009
Decision Date	04/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review