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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 / March 2026 / K260375

510(k) cleared

Nd: YAG Laser Therapy Systems

Sanhe Meditech Co., Ltd. · Mar 31, 2026 · K260375

FDA cleared the Nd: YAG Laser Therapy Systems from Sanhe Meditech Co., Ltd. on Mar 31, 2026 under K260375, 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 Feb 5, 2026. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

Sanhe Meditech Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260257 (CO2 Laser System), K252427 (Diode Laser Hair Removal Machine (GLD01)).

Questions & Answers

What did FDA clear under K260375?

K260375 is the FDA 510(k) for Nd: YAG Laser Therapy Systems, submitted by Sanhe Meditech Co., Ltd.. FDA's decision date was Mar 31, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Nd: YAG Laser Therapy Systems?

Sanhe Meditech Co., Ltd., based in Sanhe, is the applicant of record for K260375.

How long did the K260375 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Mar 31, 2026, 54 days later.

← All decisions in March 2026

Sources