The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Avaira Vitality (fanfilcon A) Soft (hydrofilic) Contact Lens.
| Device ID | K160803 |
| 510k Number | K160803 |
| Device Name: | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CooperVision, Inc. 6150 Stoneridge Mall Rd., Suite 370 Pleasanton, CA 94588 |
| Contact | Roya Borazjani |
| Correspondent | Dan O'mara CooperVision, Inc. 2090 High Point Drive Suite 100 Victor, NY 14564 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2016-07-13 |
| Summary: | summary |