The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Freshlook One-day Color Contact Lens.
| Device ID | K050213 |
| 510k Number | K050213 |
| Device Name: | FRESHLOOK ONE-DAY COLOR CONTACT LENS |
| Classification | Lens, Contact, (disposable) |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Contact | Angela L Bunn |
| Correspondent | Angela L Bunn CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-31 |
| Decision Date | 2005-03-28 |
| Summary: | summary |