Home Three Innovative Devices for Drug-Resistant Epilepsy Cleared by NMPA

Three Innovative Devices for Drug-Resistant Epilepsy Cleared by NMPA

Oct 29, 2025 17:40 CST Updated 17:40
GenLight

Innovative Medical Device Solution Provider

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Recently, the National Medical Products Administration approved the registration applications for three innovative products from Hangzhou Genlight Neurotech Co., Ltd.: an MRI-guided semiconductor laser treatment device, a single-use laser fiber optic kit, and stereotactic surgical planning software. Below are the product details:

The magnetic resonance monitored semiconductor laser therapy device consists of a main unit and accessories. The single-use laser fiber kit is composed of a medical fiber catheter assembly and cooling water tubing. The stereotactic surgical planning software includes an installation USB drive and a security key. The magnetic resonance monitored semiconductor laser therapy device is used in conjunction with the single-use laser fiber kit.For laser treatment of local lesions in patients with drug-resistant epilepsy (focal seizures, with a clearly identified epileptogenic zone or a defined epileptic conduction pathway).The stereotactic surgical planning software, used in conjunction with the magnetic resonance-guided semiconductor laser treatment device, is applied for the formulation of head stereotactic surgical plans.


This product can minimize the damage of the surgical pathway to normal brain tissue and better preserve cognitive function.


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Registration Technical Review Report
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