510(k) K050213

FRESHLOOK ONE-DAY COLOR CONTACT LENS by Ciba Vision Corporation — Product Code MVN

K050213 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "FRESHLOOK ONE-DAY COLOR CONTACT LENS". The FDA issued a decision of Substantially Equivalent on March 28, 2005. 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
March 28, 2005
Date Received
January 31, 2005
Clearance Type
Traditional
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