Alcon Laboratories, Inc. · Class II · Cleared Feb 13, 2026
| K-number | K254052 |
| Device name | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal |
| Applicant | Alcon Laboratories, Inc. |
| Product code | LPL |
| Device class | Class II |
| Decision date | Feb 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 886.5925 |
DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal are daily disposable soft contact lenses made from delefilcon A silicone hydrogel material. They optically correct refractive errors (myopia and hyperopia) and presbyopia in non-diseased eyes, with a light blue tint for easier handling. The lenses are single-use only and discarded after each daily wear period.
The subject device differs from the predicate device only in updated lens dimensional specifications (base curve, diameter, and power). All other characteristics remain identical: same silicone hydrogel material with ~33% water content and water gradient surface treatment, same chemical composition (delefilcon A with light blue tint), same design geometry, and same manufacturing process.
Not stated in this summary.
Substantial equivalence is demonstrated through nonclinical stability testing showing the subject device's stability characteristics match the predicate, and clinical trials proving noninferiority across all primary and key exploratory effectiveness endpoints. The dimensional specification changes do not alter lens design, geometry, materials, manufacturing, or performance characteristics, and clinical findings show no additional safety concerns under daily-wear, single-use conditions.
View the full FDA submission: accessdata.fda.gov