510(k) K083757

BPZ02 MULTIPURPOSE SOLUTION by Bausch & Lomb, Inc. — Product Code LYL

K083757 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BPZ02 MULTIPURPOSE SOLUTION". The FDA issued a decision of Substantially Equivalent on November 18, 2009. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), 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
November 18, 2009
Date Received
December 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type