510(k) K030522

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

K030522 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 September 12, 2003. The device falls under product code LPN (Accessories, Soft Lens Products), 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
September 12, 2003
Date Received
February 19, 2003
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