GIGAAMed’s 980nm, 1470nm and 1940nm medical diode lasers have just been granted FDA approval under K241791.

GIGAAMed Secures FDA K241791 Certification – The Only Chinese Company Certified for 980nm, 1470nm, and 1940nm Wavelengths

GIGAAMed, a global leader in medical laser technology, proudly announces that its latest product has officially received FDA K241791 certification. This certification covers the 980nm, 1470nm, and 1940nm wavelengths, making GIGAAMed the only company in China to hold an FDA approval for all three wavelengths. This achievement further strengthens GIGAAMed’s position in the international market and underscores its commitment to innovation and regulatory excellence

A Milestone in Medical Laser Technology

The K241791 certification is a testament to GIGAAMed’s cutting-edge research and development, ensuring the highest standards of safety and effectiveness. The 980nm, 1470nm, and 1940nm wavelengths are widely used in soft tissue surgery, vascular treatments, tissue ablation, and dermatological procedures, offering advanced solutions for medical professionals worldwide.

This achievement follows GIGAAMed’s 2024 FDA K230047 certification, which validated the company’s expertise in dental laser applications. With both certifications, GIGAAMed now provides an even broader range of high-performance medical laser solutions to healthcare providers.

Expanding Global Market Presence

With FDA approval, GIGAAMed is set to accelerate its expansion in the U.S. market, forging new partnerships with medical institutions, distributors, and industry leaders. The company will showcase its innovative laser technology through international exhibitions, professional seminars, and digital marketing strategies, ensuring that more medical professionals can benefit from its groundbreaking solutions.