510(k) K033919 ยท LPL Lenses, Soft Contact, Daily Wear
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
| Applicant | Ciba Vision Corporation, Duluth GA, US |
| Decision | Substantially Equivalent, Mar 12, 2004 |
| Received | Dec 18, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2007 | Ciba Vision Corporation OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package). Terminated |
LPM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.