The following data is part of a premarket notification filed by Soflex Contact Lens Industries Ltd. with the FDA for Eye-q (xylofilcon A) Soft (hydrophilic) Multifocal Contact Lens For Daily Wear.
| Device ID | K013469 |
| 510k Number | K013469 |
| Device Name: | EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SOFLEX CONTACT LENS INDUSTRIES LTD. 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SOFLEX CONTACT LENS INDUSTRIES LTD. 13 RED FOX LN. Littleton, CO 80127 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-18 |
| Decision Date | 2001-11-20 |