510(k) K072777

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES by Ciba Vision Corporation — Product Code LPL

K072777 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on January 24, 2008. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), 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
January 24, 2008
Date Received
September 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type