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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 / June 2026 / K253004

510(k) cleared

LUNA 3D

Lap GmbH Laser Applikationen · Jun 4, 2026 · K253004

FDA cleared the LUNA 3D from Lap GmbH Laser Applikationen on Jun 4, 2026 under K253004, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 258 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 Lap GmbH Laser Applikationen in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253004?

K253004 is the FDA 510(k) for LUNA 3D, submitted by Lap GmbH Laser Applikationen. FDA's decision date was Jun 4, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the LUNA 3D?

Lap GmbH Laser Applikationen, based in Lüneburg, is the applicant of record for K253004.

How long did the K253004 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jun 4, 2026, 258 days later.

← All decisions in June 2026