510(k) K042176

AQUIFY LENS COMFORT DROPS by Ciba Vision Corporation — Product Code LPN

K042176 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "AQUIFY LENS COMFORT DROPS". The FDA issued a decision of Substantially Equivalent on November 3, 2004. 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
November 3, 2004
Date Received
August 11, 2004
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