FDA 510(k) Application Details - K120732

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K120732
Device Name	Unit, Phacofragmentation
Applicant	ALCON LENSX, INC. 733 BOLSANA DRIVE LAGUNA BEACH, CA 92651 US Other 510(k) Applications for this Company
Contact	Judy Gordon Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2012
Decision Date	09/06/2012
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