The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus Multifocal.
| Device ID | K153642 |
| 510k Number | K153642 |
| Device Name: | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, 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 | 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 |