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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 / October 2025 / K242227

510(k) cleared

GENEO X ELITE

Pollogen, Ltd. · Oct 12, 2025 · K242227

FDA cleared the GENEO X ELITE from Pollogen, Ltd. on Oct 12, 2025 under K242227, a traditional 510(k). The device falls under product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, regulated at 21 CFR 878.4420 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 30, 2024. The decision came 439 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Pollogen, Ltd. has 2 other decisions in the tracker over the last 12 months: K252576 (Legend X Platform), K250734 (OptiLUV Device).

Questions & Answers

What did FDA clear under K242227?

K242227 is the FDA 510(k) for GENEO X ELITE, submitted by Pollogen, Ltd.. FDA's decision date was Oct 12, 2025, under product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

Who makes the GENEO X ELITE?

Pollogen, Ltd., based in Tel Aviv, is the applicant of record for K242227.

How long did the K242227 review take?

FDA received the submission on Jul 30, 2024 and issued its decision on Oct 12, 2025, 439 days later.

← All decisions in October 2025

Sources