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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 / September 2025 / K250734

510(k) cleared

OptiLUV Device

Pollogen, Ltd. · Sep 10, 2025 · K250734

FDA cleared the OptiLUV Device from Pollogen, Ltd. on Sep 10, 2025 under K250734, a traditional 510(k). The device falls under product code PBX, Massager, Vacuum, Radio Frequency Induced Heat, 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 Mar 11, 2025. The decision came 183 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: K242227 (GENEO X ELITE), K252576 (Legend X Platform).

Questions & Answers

What did FDA clear under K250734?

K250734 is the FDA 510(k) for OptiLUV Device, submitted by Pollogen, Ltd.. FDA's decision date was Sep 10, 2025, under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Who makes the OptiLUV Device?

Pollogen, Ltd., based in Tel Aviv, is the applicant of record for K250734.

How long did the K250734 review take?

FDA received the submission on Mar 11, 2025 and issued its decision on Sep 10, 2025, 183 days later.

← All decisions in September 2025

Sources