Submission Details
| 510(k) Number | K190045 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 09, 2019 |
| Decision Date | February 06, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
Feb 2019
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K190045 is an FDA 510(k) clearance for the DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on February 6, 2019, 28 days after receiving the submission on January 9, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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