WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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).

Alcon Laboratories, Inc. has one other decision in the tracker over the last 12 months: K252682 (LenSx Laser System (8065000944)).

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

Sources