Fotonmedix High-Power Laser Rehabilitation Device Secures FDA Certification, Accelerating Global Expansion

Recently, information published on the official website of the U.S. Food and Drug Administration (FDA) revealed that the high-power laser rehabilitation device independently developed and manufactured by Fotonmedix (Xiamen) Semiconductor Technology Co., Ltd. (hereinafter referred to as “Fotonmedix Semiconductor Technology”) has obtained FDA certification, marking the product’s compliance with U.S. medical device safety and efficacy standards and granting it access to the North American market.

01 The Highest Global Certification—Empowering Health with Professionalism

Safety is the eternal theme of medical devices, and every high-power laser device carries the health and hope of patients. Fotonmedix Semiconductor Technology possesses globally leading semiconductor laser technology, with a team that has been researching and designing high-end semiconductor lasers and modules for over 16 years. The company is at the forefront of global technology, capable of designing laser solutions and independently developing and manufacturing lasers and modules. Its products have been exported to major developed markets worldwide, including Germany, France, Switzerland, the U.S., Israel, and Japan, providing core technical support for medical devices. The successful FDA certification of Fotonmedix‘s high-power laser rehabilitation device is not only an authoritative recognition of the company’s strength but also a significant boost to the internationalization of medical technology.

02 Professional Rehabilitation—Guarding Health with Precision Therapy

The Fotonmedix High-Power Laser Rehabilitation Device is a high-energy laser device specifically designed for rehabilitation and physical therapy. With its outstanding performance and high cost-effectiveness, it has become a star product in Fotonmedix‘s laser device lineup. The device offers multiple wavelength options, with a maximum power of 45W, precisely meeting diverse rehabilitation needs. It comes preloaded with over 1,000 treatment protocols, covering a wide range of common conditions, and features user-friendly operation. Additionally, it is equipped with 7 different treatment heads, allowing flexible selection based on the treatment area and requirements, making it suitable for various application scenarios. Whether in hospital rehabilitation departments or professional rehabilitation centers, the Fotonmedix High-Power Laser Rehabilitation Device is an ideal choice for rehabilitation equipment.

03 Cutting-Edge Strength—Leading the Frontier of Laser Technology

Fotonmedix Semiconductor Technology has collaborated with Tsinghua Strait Research Institute to establish the “High-Power Laser Medicine and Semiconductor Laboratory”, dedicated to promoting innovative applications of semiconductor laser technology in the medical field. Through in-depth clinical research, the partnership drives semiconductor laser technology innovation, focusing on the R&D and production of laser-based medical and home-use devices for minimally invasive surgery, dentistry, vascular surgery, urology, photodynamic therapy (PDT), orthopedics, rehabilitation, and medical aesthetics.

In the future, we will continue to uphold the principle of “Quality First, Compliance Above All”, adhering to the highest standards of quality while deepening technological R&D. We aim to provide superior products and services, bringing health and hope to patients worldwide. We look forward to collaborating with global partners to lead the industry toward a brighter future.

About Fotonmedix 

Fotonmedix is an innovative high-power laser medical device manufacturer, specializing in the R&D and production of laser-based medical and home-use devices for minimally invasive surgery, dentistry, vascular surgery, urology, photodynamic therapy (PDT), orthopedics, rehabilitation, and medical aesthetics. The company’s self-developed high-power lasers have been exported to major developed markets worldwide, including Germany, France, Switzerland, the U.S., Israel, and Japan. By combining advanced high-power laser technology with cutting-edge medical clinical research, Fotonmedix is committed to designing and developing exceptional high-power medical laser devices, providing safe, comfortable, and effective health solutions for global clients.