510(k) K022687

AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION by Ciba Vision Corporation — Product Code LYL

K022687 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION". The FDA issued a decision of Substantially Equivalent on November 19, 2002. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2002
Date Received
August 13, 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