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 / K252576

510(k) cleared

Legend X Platform

Pollogen, Ltd. · Sep 12, 2025 · K252576

FDA cleared the Legend X Platform from Pollogen, Ltd. on Sep 12, 2025 under K252576, a special 510(k) reviewed through the Third Party Review Program. 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 Aug 14, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Pollogen, Ltd. has 2 other decisions in the tracker over the last 12 months: K242227 (GENEO X ELITE), K250734 (OptiLUV Device).

Questions & Answers

What did FDA clear under K252576?

K252576 is the FDA 510(k) for Legend X Platform, submitted by Pollogen, Ltd.. FDA's decision date was Sep 12, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Legend X Platform?

Pollogen, Ltd., based in Tel Aviv, is the applicant of record for K252576.

How long did the K252576 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Sep 12, 2025, 29 days later.

← All decisions in September 2025

Sources