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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 / February 2026 / K252048

510(k) cleared

808nm semiconductor laser hair removal machine

Xi'An Taibo Electronic Technology Co., Ltd. · Feb 3, 2026 · K252048

FDA cleared the 808nm semiconductor laser hair removal machine from Xi'An Taibo Electronic Technology Co., Ltd. on Feb 3, 2026 under K252048, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, 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 Jun 30, 2025. The decision came 218 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Xi'An Taibo Electronic Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252048?

K252048 is the FDA 510(k) for 808nm semiconductor laser hair removal machine, submitted by Xi'An Taibo Electronic Technology Co., Ltd.. FDA's decision date was Feb 3, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the 808nm semiconductor laser hair removal machine?

Xi'An Taibo Electronic Technology Co., Ltd., based in Xi'An, is the applicant of record for K252048.

How long did the K252048 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Feb 3, 2026, 218 days later.

← All decisions in February 2026