WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K242859

510(k) cleared

VEGA

Ibramed Equipamentos Médicos · Sep 19, 2025 · K242859

FDA cleared the VEGA from Ibramed Equipamentos Médicos on Sep 19, 2025 under K242859, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 20, 2024. The decision came 364 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 Ibramed Equipamentos Médicos in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242859?

K242859 is the FDA 510(k) for VEGA, submitted by Ibramed Equipamentos Médicos. FDA's decision date was Sep 19, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the VEGA?

Ibramed Equipamentos Médicos, based in Amparo, is the applicant of record for K242859.

How long did the K242859 review take?

FDA received the submission on Sep 20, 2024 and issued its decision on Sep 19, 2025, 364 days later.

← All decisions in September 2025