K202036 is an FDA 510(k) clearance for the Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal. This device is classified as a Lens, Contact, (disposable) (Class II - Special Controls, product code MVN).
Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on August 21, 2020, 29 days after receiving the submission on July 23, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K202036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2020 |
| Decision Date | August 21, 2020 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MVN — Lens, Contact, (disposable) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |