The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Proclear Toric Xr Soft (hydrophilic) Contact Lens; Proclear Multifocal Xr Soft (hydrophilic) Contact Lens; Proclear Mult.
| Device ID | K110099 |
| 510k Number | K110099 |
| Device Name: | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
| Contact | Sarah Harrington |
| Correspondent | Sarah Harrington COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 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 | 2011-01-13 |
| Decision Date | 2011-06-29 |
| Summary: | summary |