Submission Details
| 510(k) Number | K182782 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 01, 2018 |
| Decision Date | January 18, 2019 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
Jan 2019
Decision
109d
Days
Class 2
Risk
About This 510(k) Submission
K182782 is an FDA 510(k) clearance for the DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric, 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 January 18, 2019, 109 days after receiving the submission on October 1, 2018. 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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