The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Ciba Vision (nelfilcon A) One-day Soft Contact Lenses.
| Device ID | K083216 |
| 510k Number | K083216 |
| Device Name: | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Contact | Martina Heim |
| Correspondent | Martina Heim CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-31 |
| Decision Date | 2009-04-14 |
| Summary: | summary |