510(k) K023455

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

K023455 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 February 28, 2003. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2003
Date Received
October 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type