DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal— 510(k) K254052
Substantially EquivalentAlcon Laboratories, Inc.
FDA 510(k) clearance K254052 for DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal, Substantially Equivalent on 2026-02-13. Applicant: Alcon Laboratories, Inc.. Device class: 2.
Summary
Alcon Laboratories lists DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal under product code LPL (Lenses, Soft Contact, Daily Wear). The record doesn't say how the two differ beyond their names.
Class II, 21 CFR 886.5925. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Alcon Laboratories filed from Fort Worth, Texas. The substantially equivalent decision came 58 calendar days after receipt (December 17, 2025 to February 13, 2026).
Clearance details
- Applicant
- Alcon Laboratories, Inc.
- Product code
- Product code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
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- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
More clearances from Alcon Laboratories, Inc.
view allAdverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.