The following data is part of a premarket notification filed by Vistakon with the FDA for Vistakon (senofilcon A) Soft Contact Lens.
| Device ID | K042275 |
| 510k Number | K042275 |
| Device Name: | VISTAKON (SENOFILCON A) SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON 3012 ST. CHARLES DR. Tampa, FL 33618 |
| Contact | Annette M Hillring |
| Correspondent | Annette M Hillring VISTAKON 3012 ST. CHARLES DR. Tampa, FL 33618 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-23 |
| Decision Date | 2004-10-28 |
| Summary: | summary |