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 / June 2026 / K260179

510(k) cleared

VITA Multi-Function Head Brush (TB-2343F, TB-2442F)

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · Jun 3, 2026 · K260179

FDA cleared the VITA Multi-Function Head Brush (TB-2343F, TB-2442F) from Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. on Jun 3, 2026 under K260179, 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 21, 2026. The decision came 133 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. has one other decision in the tracker over the last 12 months: K252053 (VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)).

Questions & Answers

What did FDA clear under K260179?

K260179 is the FDA 510(k) for VITA Multi-Function Head Brush (TB-2343F, TB-2442F), submitted by Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. FDA's decision date was Jun 3, 2026, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the VITA Multi-Function Head Brush (TB-2343F, TB-2442F)?

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd., based in Shenzhen, is the applicant of record for K260179.

How long did the K260179 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Jun 3, 2026, 133 days later.

← All decisions in June 2026

Sources