510(k) K133242

STELLARIS VISION ENHANCEMENT SYSTEM by Bausch & Lomb — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2014
Date Received
October 21, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type