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FDA approves InnoVoyce’s VYLO Laser System for medical use

InnoVoyce's VYLO Laser System has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The VYLO Laser System, using a 455nm blue light laser, delivers up to 30W across four emission modes. It's crafted for surgical applications like incision/excision, vaporization, and ablation, along with providing hemostasis and coagulation in soft tissue, muscle, organs, and glands.

Designed to cater to various surgical needs, the VYLO Laser System enables precise cuts and significant soft tissue mass removal. Its versatility makes it suitable for applications in gynecology, gastroenterology, otorhinolaryngology, and other surgical fields.

The blue light lasers of the system emit beams between 400nm and 500nm, proving effective in treating soft tissues, particularly in laryngology and ear, nose, and throat (ENT) medicine. Additionally, the VYLO system incorporates the patent-pending FiberSafe technology, ensuring automatic laser standby mode activation in case of fiber flare-ups. This safety feature minimizes operational risks and enhances system reliability.