The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Glitter Eyes (tefilcon) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K003071 |
| 510k Number | K003071 |
| Device Name: | GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Contact | Terrina Wilder |
| Correspondent | Terrina Wilder CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. 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 | 2000-10-02 |
| Decision Date | 2000-12-13 |