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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 / K243854

510(k) cleared

Contour Light (CL-100)

Contour Research, LLC · Feb 13, 2026 · K243854

FDA cleared the Contour Light (CL-100) from Contour Research, LLC on Feb 13, 2026 under K243854, a special 510(k). The device falls under product code OLI, Fat Reducing Low Level Laser, regulated at 21 CFR 878.5400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 16, 2024. The decision came 424 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 Contour Research, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243854?

K243854 is the FDA 510(k) for Contour Light (CL-100), submitted by Contour Research, LLC. FDA's decision date was Feb 13, 2026, under product code OLI (Fat Reducing Low Level Laser).

Who makes the Contour Light (CL-100)?

Contour Research, LLC, based in Reno, NV, is the applicant of record for K243854.

How long did the K243854 review take?

FDA received the submission on Dec 16, 2024 and issued its decision on Feb 13, 2026, 424 days later.

← All decisions in February 2026