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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 / K253484

510(k) cleared

LUTRONIC GENIUS

Cynosure Lutronic Technology Corporation · Jun 29, 2026 · K253484

FDA cleared the LUTRONIC GENIUS from Cynosure Lutronic Technology Corporation on Jun 29, 2026 under K253484, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Oct 17, 2025. The decision came 255 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 Cynosure Lutronic Technology Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253484?

K253484 is the FDA 510(k) for LUTRONIC GENIUS, submitted by Cynosure Lutronic Technology Corporation. FDA's decision date was Jun 29, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the LUTRONIC GENIUS?

Cynosure Lutronic Technology Corporation, based in Goyang Gyeonggi, is the applicant of record for K253484.

How long did the K253484 review take?

FDA received the submission on Oct 17, 2025 and issued its decision on Jun 29, 2026, 255 days later.

← All decisions in June 2026