Three Innovative Neurosurgical Devices by Hangzhou Jialiang Medical Receive NMPA Approval

On October 29, 2025, the National Medical Products Administration approved Hangzhou Genlight Neurotech Co., Ltd.'s"Magnetic Resonance-Guided Semiconductor Laser Therapy Device" (Registration No. 20253012081), "Single-Use Laser Fiber Optic Kit" (Registration No. 20253012082), and "Stereotactic Surgical Planning Software" (Registration No. 20253212083)Registration applications for 3 innovative products.

As of now, the cumulative number of innovative medical devices listed in China has reached 377.

# Approval Information

The magnetic resonance-guided semiconductor laser treatment device consists of a main unit and accessories. The single-use laser fiber kit is composed of a medical fiber optic catheter assembly and cooling water tubing. The stereotactic surgical planning software includes an installation USB drive and a security key.

Magnetic Resonance-Guided Semiconductor Laser Therapy Device Used in Conjunction with Single-Use Laser Fiber Optic KitMainly used for laser ablation treatment of local lesions in patients with drug-resistant epilepsy (focal seizures, with a clear epileptogenic zone or conduction pathway); stereotactic surgical planning software is used in conjunction with equipment for planning and formulating the surgical path in head stereotactic surgeries.

The product utilizes magnetic resonance imaging for precise monitoring during surgery, minimizing damage to normal brain tissue from the surgical pathway as much as possible, better preserving the patient's cognitive function, and enhancing the safety and accuracy of the treatment.

The above three products form the core components of Genlight Neurotech's LaserRO™ MRI-guided laser ablation minimally invasive surgical system, marking a significant breakthrough in domestically produced MRI-guided neurosurgical minimally invasive treatment equipment.

# Company Introduction

Genlight Neurotech, established in 2020 and located in Hangzhou Future Sci-Tech City, is a high-tech platform enterprise dedicated to the industrialization of cutting-edge technologies in the fields of brain science and neurosurgery.

The company has built three major technology platforms: brain-computer modulation, medical lasers, and brain-computer chips, committed to providing innovative therapeutic devices and comprehensive solutions for various neurological disorders such as epilepsy, Parkinson's disease, and depression.

Genlight Neurotech has established a dual-headquarters layout (Hangzhou—Singapore) both in China and internationally, with GMP production facilities and professional R&D centers, continuously driving the independent innovation and global application of domestically produced high-end neurosurgical operation systems.

# Core Product Layout

(1) LaserRO™ MRI-guided Laser Ablation Minimally Invasive Surgical System

Registration Certificate Number: China Medical Device Registration No. 20253012081 / 20253012082 / 20253212083
LaserRO™ Magnetic Resonance-guided Laser Ablation System (MRgLITT) is an advanced minimally invasive surgical technique that combines real-time monitoring with magnetic resonance imaging (MRI) to precisely deliver thermal energy via laser fiber to the lesion area, achieving targeted ablation of diseased tissue.
The system is excellent withAccuracy, Minimally Invasiveness, and Flexibility, providing a new treatment option for patients with drug-resistant epilepsy, which can significantly reduce the damage of surgical pathways to normal brain tissue and better preserve cognitive function.
The LaserRO™ system consists of three parts:

• MRI-Monitored Semiconductor Laser Therapy Device(Main Unit and Accessories)

• Disposable Laser Fiber Optic Kit(Fiber Optic Catheter and Cooling Water Pipe)

• Stereotactic Surgical Planning Software(For Path Planning and Energy Control)

(II) S-Deep™ Intracranial Deep Electrode

Registration Certificate Number: China Medical Device Registration No. 20253071815
S-Deep™ Intracranial Depth Electrodes are a key component of stereoelectroencephalography (SEEG) technology. By precisely implanting electrodes into brain tissue, they can record electrical activity in deep brain regions, providing crucial evidence for the diagnosis and preoperative localization of refractory epilepsy.
The product utilizes high-precision insulating and flexible materials, balancing signal acquisition stability with patient safety, enabling multi-channel, deep-level EEG signal monitoring.

(III) Epiclure™ Implantable Closed-Loop Self-Responsive Neurostimulation System

The Epiclure™ system continuously monitors brain activity through implanted neural electrodes. When abnormal discharges or early signals of epileptic seizures are detected, the system can automatically trigger an electrical stimulation program to balance abnormal brain activity, thereby effectivelyPrevent or alleviate epileptic seizures。
This system provides patients with a safe and reliable closed-loop neuromodulation method, representing an important application extension in the field of brain-computer modulation.

# Conclusion

The three innovative products approved this time for Genlight Neurotech have opened a new technological dimension for domestically produced neurosurgical equipment.

The innovative integration of three key components—real-time MRI monitoring, precise laser energy delivery, and intraoperative pathway planning—has enabled higher visualization and controllability in the treatment of complex brain disorders such as focal epilepsy. This also marks the accelerated entry of domestically produced devices into the "minimally invasive era" of advanced neuromodulation in China.

The significance of such innovations lies not only in filling the technical gaps of individual products but also in establishing a clinical system that integrates imaging, energy, and algorithms. From a long-term perspective, brain science is becoming a new growth driver for innovation in high-end medical devices produced in China, and companies like GenLight are using an engineering approach to explore the independent evolution of Chinese-style neurosurgical equipment.