Submission Details
| 510(k) Number | K033919 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2003 |
| Decision Date | March 12, 2004 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
Mar 2004
Decision
85d
Days
Class 2
Risk
About This 510(k) Submission
K033919 is an FDA 510(k) clearance for the CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on March 12, 2004, 85 days after receiving the submission on December 18, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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