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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 / February 2026 / K252175

510(k) cleared

LANDR Contact LENS Case

Fourth Axis, LLC · Feb 10, 2026 · K252175

FDA cleared the LANDR Contact LENS Case from Fourth Axis, LLC on Feb 10, 2026 under K252175, a traditional 510(k). The device falls under product code LRX, Case, Contact Lens, regulated at 21 CFR 886.5928 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jul 11, 2025. The decision came 214 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Fourth Axis, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252175?

K252175 is the FDA 510(k) for LANDR Contact LENS Case, submitted by Fourth Axis, LLC. FDA's decision date was Feb 10, 2026, under product code LRX (Case, Contact Lens).

Who makes the LANDR Contact LENS Case?

Fourth Axis, LLC, based in Boise, ID, is the applicant of record for K252175.

How long did the K252175 review take?

FDA received the submission on Jul 11, 2025 and issued its decision on Feb 10, 2026, 214 days later.

← All decisions in February 2026