510(k) K113852

BAUSCH & LOMB IOL INJECTOR by Bausch & Lomb, Inc. — Product Code MSS

K113852 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BAUSCH & LOMB IOL INJECTOR". The FDA issued a decision of Substantially Equivalent on September 28, 2012. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2012
Date Received
December 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type