The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Proclear, Proclear Toric, Proclear Multifocal, Proclear 1day, Proclear Xc.
| Device ID | K111966 |
| 510k Number | K111966 |
| Device Name: | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
| Contact | Lisa Hahn |
| Correspondent | Lisa Hahn 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 | 2011-07-11 |
| Decision Date | 2011-09-15 |
| Summary: | summary |