Sierra Medical Secures China's First Class III Certificate for Disposable Intraocular Laser Fiber, Accelerating Innovation

Jan 07, 2026 17:01 CST Updated 17:01

Sierra Medical

Innovative Medical Device Developer

Source: Eye Future

Reprint Requirements: Can be reprinted 24 hours after the first publicationLoad, need to indicate the source.Source

December 31, 2025, Sierra MedicalGALUXY^®Disposable Intraocular Laser Fiber, officially obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA).

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 optic design does not pursue "conceptual innovation" but rather focuses on engineering optimization based on real surgical needs.

Elastic Nickel-Titanium Elbow Structure

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

About38° Angle Design

Can cover approximately behind the limbusA 6mm peripheral retinal area, providing a more natural instrument posture for peripheral lesion treatment.

FineFiber Core Diameter and Small Divergence Angle

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

These designs need to undergo 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 portfolio, it is more like a crucial 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:

2025First Half of the Year，Ultra-high Speed Vitrectomy Probe、IntraocularThe puncture device has been registered and launched;
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 approval expected by 2026.

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

Conclusion

From vitrectomy probes, trocars, and laser fibers to the ongoing development of phaco-vitrectomy machines/phacoemulsification machines and accompanying consumables, Sierra Medical is steadily advancing along a clear and systematic product roadmap.

Against the backdrop of China-produced ophthalmic devices continuously advancing towards the high-end market, this approach focused on long-term capabilities offers a more valuable reference for building external judgment and confidence.

This company is in a period of vigorous growth.、Full of Infinite Possibilities's rising enterprise, its subsequent development is worthContinuousFollow。

Statement

Content Declaration:"Eye on the Future" tracks global medical technology advancements, aiming to disseminate technical and industry knowledge. All content is intended for professional exchange and academic discussion only, and does not constitute medical advice or commercial promotion. Information regarding companies, products, and registration mentioned in the text is sourced from publicly available materials or verified channels. If there are any errors or omissions, please contact us for corrections. Email: jacky@suribot.com

Copyright Statement:"The Future of Ophthalmology" original manuscripts are copyrighted by Beijing Siyubo Technology Co., Ltd. Unauthorized reproduction, excerpting, or mirroring on other websites, official accounts, or commercial platforms is prohibited; for authorized reproduction, please contact the backstage to obtain permission. This platform reserves the right to pursue legal responsibility for unauthorized full-text reproduction, rewriting, or paraphrasing.