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, Dailies Aquacomfort Plus (dacp) / Dacp Toric / Dacp Multifocal, Freshlook One-day, Dailies Total1, Dailies Total1 Multifocal.
| Device ID | K180398 |
| 510k Number | K180398 |
| Device Name: | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 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 Alcon / CIBA Vision GmbH Industriering 1 Grosswallstadt, DE 63868 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-13 |
| Decision Date | 2018-04-10 |
| Summary: | summary |