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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 / September 2025 / K252682

510(k) cleared

LenSx Laser System (8065000944)

Alcon Laboratories, Inc. · Sep 24, 2025 · K252682

FDA cleared the LenSx Laser System (8065000944) from Alcon Laboratories, Inc. on Sep 24, 2025 under K252682, a special 510(k). The device falls under product code OOE, Ophthalmic Femtosecond Laser, regulated at 21 CFR 886.4390 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Aug 25, 2025. The decision came 30 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: K254052 (DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal).

Questions & Answers

What did FDA clear under K252682?

K252682 is the FDA 510(k) for LenSx Laser System (8065000944), submitted by Alcon Laboratories, Inc.. FDA's decision date was Sep 24, 2025, under product code OOE (Ophthalmic Femtosecond Laser).

Who makes the LenSx Laser System (8065000944)?

Alcon Laboratories, Inc., based in Fort Worth, TX, is the applicant of record for K252682.

How long did the K252682 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Sep 24, 2025, 30 days later.

← All decisions in September 2025

Sources