The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Myday (stenfilcon A) Soft (hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (hydrophilic) Contact Lens.
| Device ID | K220070 |
| 510k Number | K220070 |
| Device Name: | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
| Contact | Marie Dutton |
| Correspondent | Marie Dutton CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-02-04 |