The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Freshtech, Dailies Aquacomfort Plus Toric And Dailies Aquacomfort Plus Multifocal.
| Device ID | K181454 |
| 510k Number | K181454 |
| Device Name: | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric And DAILIES AquaComfort Plus Multifocal |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Contact | Sherri Lakota |
| Correspondent | Katryna Warren Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2018-11-21 |