510(k) K020802

RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION by Bausch & Lomb, Incorporated — Product Code LYL

K020802 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION". The FDA issued a decision of Substantially Equivalent on May 31, 2002. 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, Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2002
Date Received
March 12, 2002
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