510(k) K111877

EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION by Bausch & Lomb, Inc. — Product Code LPN

K111877 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION". The FDA issued a decision of Substantially Equivalent on January 24, 2012. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2012
Date Received
July 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type