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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 / K252053

510(k) cleared

VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)

Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd · Oct 27, 2025 · K252053

FDA cleared the VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) from Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd on Oct 27, 2025 under K252053, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 1, 2025. The decision came 118 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: K260179 (VITA Multi-Function Head Brush (TB-2343F, TB-2442F)).

Questions & Answers

What did FDA clear under K252053?

K252053 is the FDA 510(k) for VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F), submitted by Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd. FDA's decision date was Oct 27, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)?

Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd, based in Shenzhen, is the applicant of record for K252053.

How long did the K252053 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Oct 27, 2025, 118 days later.

← All decisions in October 2025

Sources