The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Focus Dailies, Focus Dailies Toric, Focus Dailies Progressives.
| Device ID | K153643 |
| 510k Number | K153643 |
| Device Name: | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Sherri Lakota |
| Correspondent | Andreas Friese CIBA VISION GMBH INDUSTERIERING Grosswallstadt, DE 63868 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-01-20 |
| Summary: | summary |