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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / February 2026 / K254052

510(k) cleared

DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

Alcon Laboratories, Inc. · Feb 13, 2026 · K254052

FDA cleared the DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal from Alcon Laboratories, Inc. on Feb 13, 2026 under K254052, a traditional 510(k). The device falls under product code LPL, Lenses, Soft Contact, Daily Wear, regulated at 21 CFR 886.5925 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Dec 17, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Alcon Laboratories, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254052?

K254052 is the FDA 510(k) for DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal, submitted by Alcon Laboratories, Inc.. FDA's decision date was Feb 13, 2026, under product code LPL (Lenses, Soft Contact, Daily Wear).

Who makes the DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal?

Alcon Laboratories, Inc., based in Fort Worth, TX, is the applicant of record for K254052.

How long did the K254052 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Feb 13, 2026, 58 days later.

← All decisions in February 2026