The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens With Uv Blocker.
| Device ID | K181920 |
| 510k Number | K181920 |
| Device Name: | Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens With UV Blocker |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CooperVision, Inc. 5870 Stoneridge Drive Suite 1 Pleasanton, CA 94588 |
| Contact | Marie Dutton |
| Correspondent | Marie Dutton CooperVision, Inc. 5870 Stoneridge Drive Suite 1 Pleasanton, CA 94588 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-18 |
| Decision Date | 2018-12-11 |
| Summary: | summary |