Sierra Medical Achieves Milestone with China's First Class III Certification for Disposable Intraocular Laser Fiber

Recently, Sierra Medical's GALUXY® disposable intraocular laser fiber has officially obtained the Class III medical device registration certificate from the National Medical Products Administration (NMPA) in China.

This is the first Class III certificate in the field of domestically produced single-use intraocular laser fiber, marking the first time that a domestically produced product has entered the clinical application system for this specific device with a higher safety standard.

Engineering Design Centered on Real Surgical Needs

This laser fiber does not pursue "conceptual innovation" in its design but focuses on engineering optimization based on real surgical needs.

Flexible Nickel-Titanium Elbow Structure

Compared with traditional stainless steel materials, the advantages of nitinol in flexibility and trackability make it more adaptable to the intraocular path when entering the trocar and treating peripheral retinal lesions, reducing operational resistance.

Approximately 38° angled design

Can cover the peripheral retinal area approximately 6mm posterior to the limbus, providing a more natural instrument posture for peripheral lesion management.

Thin optical fiber core diameter and small divergence angle

While ensuring high energy transmission efficiency, improve targeting accuracy; control the spot size within a certain distance from the light outlet to allow for a safety margin during operation.

These designs require system verification under the Class III device framework, with the goal being not parameter performance but long-term, stable clinical usability.

A Gradually Forming Product Pathway

If we only look at this laser fiber, it is a "Class III system entry" consumable;

But within Sierra Medical's overall product layout, it is more like a critical puzzle piece that is being put into place.

Over the past year or so, this relatively young company has maintained a remarkably clear product rhythm:

• In the first half of 2025, the ultra-high-speed vitrectomy cutter and intraocular puncture device will complete registration and be launched on the market;

• By the end of the same year, the disposable intraocular laser fiber was approved;

• The all-in-one phacoemulsification and vitrectomy machine, phacoemulsification machine, and their配套耗材 (supporting consumables) are also progressing steadily, with an expected approval by 2026.

This path is not a "single-point breakthrough" but a systematic advancement around the high-end integrated ophthalmic surgical platform, gradually filling in the gaps in key equipment and consumables.

Sierra Medical, established in July 2022, is an innovative medical device company integrating research and development, production, and sales. It focuses on providing precise, intelligent, minimally invasive surgical treatment solutions for ophthalmology. Its current products under development mainly include phacoemulsification and vitrectomy machines with their accompanying consumables, as well as advanced ophthalmic surgical instruments such as digital surgical microscopes.