510(k) K112909

OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION by Bausch & Lomb, Inc. — Product Code LPN

K112909 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION". The FDA issued a decision of Substantially Equivalent on April 30, 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
April 30, 2012
Date Received
October 3, 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