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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 / K251944

510(k) cleared

Lipocosm Harmonic System

Lipocosm, LLC · Jun 8, 2026 · K251944

FDA cleared the Lipocosm Harmonic System from Lipocosm, LLC on Jun 8, 2026 under K251944, a traditional 510(k). The device falls under product code QPB, System, Suction, Lipoplasty For Removal, regulated at 21 CFR 878.5040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 24, 2025. The decision came 349 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 Lipocosm, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251944?

K251944 is the FDA 510(k) for Lipocosm Harmonic System, submitted by Lipocosm, LLC. FDA's decision date was Jun 8, 2026, under product code QPB (System, Suction, Lipoplasty For Removal).

Who makes the Lipocosm Harmonic System?

Lipocosm, LLC, based in Key Biscayne, FL, is the applicant of record for K251944.

How long did the K251944 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Jun 8, 2026, 349 days later.

← All decisions in June 2026