The following data is part of a premarket notification filed by Cooper Vision, Inc. with the FDA for Proclear Toric Xr, Proclear Multifocal Xr, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses.
| Device ID | K112302 |
| 510k Number | K112302 |
| Device Name: | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPER VISION, INC. 6150 STONERIDGE MALL ROAD Pleasanton, CA 94588 |
| Contact | Lisa Hahn |
| Correspondent | Lisa Hahn COOPER VISION, INC. 6150 STONERIDGE MALL ROAD 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 | 2011-08-11 |
| Decision Date | 2011-12-21 |
| Summary: | summary |