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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 / May 2026 / K260895

510(k) cleared

Ulike Clear Zero (YC10 BU)

Guangxi Ulike Medical Technology Co., Ltd. · May 28, 2026 · K260895

FDA cleared the Ulike Clear Zero (YC10 BU) from Guangxi Ulike Medical Technology Co., Ltd. on May 28, 2026 under K260895, a traditional 510(k). The device falls under product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 18, 2026. The decision came 71 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Guangxi Ulike Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260895?

K260895 is the FDA 510(k) for Ulike Clear Zero (YC10 BU), submitted by Guangxi Ulike Medical Technology Co., Ltd.. FDA's decision date was May 28, 2026, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the Ulike Clear Zero (YC10 BU)?

Guangxi Ulike Medical Technology Co., Ltd., based in Yulin, is the applicant of record for K260895.

How long did the K260895 review take?

FDA received the submission on Mar 18, 2026 and issued its decision on May 28, 2026, 71 days later.

← All decisions in May 2026