Submission Details
| 510(k) Number | K202036 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
Aug 2020
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | MVN — Lens, Contact, (disposable) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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