510(k) K254052

DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal by Alcon Laboratories, Inc. — Product Code LPL

K254052 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
December 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type