The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Avaira Spheric And Toric (enfilcon A) Soft Contact Lens.
| Device ID | K133627 |
| 510k Number | K133627 |
| Device Name: | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
| Contact | Annette Nelson |
| Correspondent | Annette Nelson COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2013-12-23 |
| Summary: | summary |