The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Dailies Colors, Dailies Colors Toric, Dailies Colors Progressives.
| Device ID | K190045 |
| 510k Number | K190045 |
| Device Name: | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Contact | Heather Smith |
| Correspondent | Heather Smith Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-09 |
| Decision Date | 2019-02-06 |
| Summary: | summary |