510(k) K073459

CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES by Ciba Vision Corporation — Product Code LPL

K073459 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on February 28, 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
February 28, 2008
Date Received
December 10, 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