Vivolight’s FastErazer 355 nm Cold Laser Atherectomy System Receives NMPA Approval in China

Shenzhen, China — June 2026 — Vivolight Medical is pleased to announce that FastErazer Three-Frequency Nd:YAG Laser Atherectomy System has received approval from China’s National Medical Products Administration, with registration number NMPA 20263011296.

Used together with disposable laser fiber catheters, FastErazer is approved in China for lesion preparation in the treatment of lower-limb arteriosclerotic stenosis, including in-stent restenosis, as well as occlusive arterial lesions. The approval marks an important milestone for China’s first 355 nm cold laser atherectomy platform and introduces a new option for endovascular vessel preparation in complex peripheral arterial disease.

Lower-limb arterial stenosis and occlusion remain major clinical challenges, especially in patients with chronic limb-threatening ischemia (CLTI), below-the-knee lesions and in-stent restenosis (ISR). These cases often require effective lumen gain while minimizing vessel trauma, distal embolization risk. FastErazer was developed to support this clinical need through a cold laser-based debulking approach that is efficient, tissue-sparing and simple to operate.

Safe - Selective Ablation

FastErazer uses a 355 nm wavelength with photon energy of approximately 3.5 eV. This supports a photochemical ablation mechanism designed to precisely modify plaque while helping minimize injury to the vessel wall.

Safe - Micro Debris

During ablation, FastErazer produces a micro-debris profile, over 99.9% of particles were smaller than 25 μm. This fine-particle ablation profile reduce embolic risk during plaque debulking. For physicians treating long, diffuse, below-the-knee or restenotic lesions, micro-debris  supports a safer approach to vessel preparation.

Effective - Nanosecond Pulse

FastErazer delivers energy through an ultra-short 15 ns pulse width, making the ablation process photomechanically dominant while helping reduce thermal diffusion. The nanosecond pulse enhances the mechanical disruption of plaque while limiting heat transfer to surrounding tissue.

Stable - Solid-State Simplicity

Unlike conventional gas-based excimer laser systems, FastErazer is built on an solid-state laser platform. The system requires no gas medium, no pre-use calibration and little maintenance effort, helping simplify daily operation in the cath lab or hybrid operating room. Its compact and mobile design further supports practical clinical use.

Designed for Complex Peripheral Lesions

FastErazer is available with multiple catheter specifications to support treatment from femoropopliteal arteries to below-the-knee vessels. The catheter portfolio includes 2.5 mm, 2.0 mm and 1.2 mm options, enabling physicians to select the appropriate device profile according to target vessel size, lesion morphology and procedural strategy.

The approval of FastErazer marks an important milestone in Vivolight’s continued development of laser-based vascular technologies,” the company stated. “By combining selective ablation, micro-debris generation, nanosecond pulse performance and solid-state simplicity, FastErazer provides a differentiated approach to lesion preparation for complex lower-limb arterial disease.

Vivolight will continue to advance laser-based vascular technologies and expand access to innovative, minimally invasive treatment solutions for patients worldwide.