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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 / November 2025 / K252658

510(k) cleared

Medical Diode Laser Systems (TR-B)

Baoding Te'Anzhou Electronic Technology Co., Ltd. · Nov 28, 2025 · K252658

FDA cleared the Medical Diode Laser Systems (TR-B) from Baoding Te'Anzhou Electronic Technology Co., Ltd. on Nov 28, 2025 under K252658, 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 Aug 22, 2025. The decision came 98 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Baoding Te'Anzhou Electronic Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252564 (Medical Diode Laser Systems (VeinCure)).

Questions & Answers

What did FDA clear under K252658?

K252658 is the FDA 510(k) for Medical Diode Laser Systems (TR-B), submitted by Baoding Te'Anzhou Electronic Technology Co., Ltd.. FDA's decision date was Nov 28, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Medical Diode Laser Systems (TR-B)?

Baoding Te'Anzhou Electronic Technology Co., Ltd., based in Baoding, is the applicant of record for K252658.

How long did the K252658 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Nov 28, 2025, 98 days later.

← All decisions in November 2025

Sources