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 / March 2026 / K260257

510(k) cleared

CO2 Laser System

Sanhe Meditech Co., Ltd. · Mar 28, 2026 · K260257

FDA cleared the CO2 Laser System from Sanhe Meditech Co., Ltd. on Mar 28, 2026 under K260257, 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 Jan 28, 2026. The decision came 59 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: K260375 (Nd: YAG Laser Therapy Systems), K252427 (Diode Laser Hair Removal Machine (GLD01)).

Questions & Answers

What did FDA clear under K260257?

K260257 is the FDA 510(k) for CO2 Laser System, submitted by Sanhe Meditech Co., Ltd.. FDA's decision date was Mar 28, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CO2 Laser System?

Sanhe Meditech Co., Ltd., based in Sanhe, is the applicant of record for K260257.

How long did the K260257 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Mar 28, 2026, 59 days later.

← All decisions in March 2026

Sources