510(k) K133146

BAUSCH + LUMB, VIS100 INJECTOR SYSTEM by Bausch & Lomb — Product Code MSS

K133146 is an FDA 510(k) premarket notification submitted by Bausch & Lomb for the device "BAUSCH + LUMB, VIS100 INJECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 2014. 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 has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2014
Date Received
October 17, 2013
Clearance Type
Special
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