The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Focus Excelens (lotrafilcon B) Spherical, Toric And Multifocal Design.
| Device ID | K020139 |
| 510k Number | K020139 |
| Device Name: | FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Contact | Alicia M Plesnarski |
| Correspondent | Alicia M Plesnarski CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-16 |
| Decision Date | 2002-04-09 |
| Summary: | summary |