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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 / October 2025 / K250227

510(k) cleared

JOVS Electric Stimulation Beauty Device (JE2)

Shenzhen Qianyu Technology Co., Ltd. · Oct 17, 2025 · K250227

FDA cleared the JOVS Electric Stimulation Beauty Device (JE2) from Shenzhen Qianyu Technology Co., Ltd. on Oct 17, 2025 under K250227, 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 Jan 27, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Qianyu Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K261851 (LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)).

Questions & Answers

What did FDA clear under K250227?

K250227 is the FDA 510(k) for JOVS Electric Stimulation Beauty Device (JE2), submitted by Shenzhen Qianyu Technology Co., Ltd.. FDA's decision date was Oct 17, 2025, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the JOVS Electric Stimulation Beauty Device (JE2)?

Shenzhen Qianyu Technology Co., Ltd., based in Shenzhen City, is the applicant of record for K250227.

How long did the K250227 review take?

FDA received the submission on Jan 27, 2025 and issued its decision on Oct 17, 2025, 263 days later.

← All decisions in October 2025

Sources