510(k) K151102

Bausch + Lomb Injector System by Bausch & Lomb, Inc. — Product Code MSS

K151102 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "Bausch + Lomb Injector System". The FDA issued a decision of Substantially Equivalent on May 22, 2015. 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
May 22, 2015
Date Received
April 24, 2015
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