510(k) K033701

FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES by Ciba Vision Corporation — Product Code MVN

K033701 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on December 15, 2003. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2003
Date Received
November 25, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, (Disposable)
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type