Medical technology company InnoVoyce has secured the US Food and Drug Administration (FDA) 510(k) clearance for its VYLO Laser System.
The VYLO Laser System is said to be the first and only 455nm blue light laser with a power capacity of up to 30W, featuring four emission modes.
InnoVoyce has designed the laser system for procedures like incision/excision, vaporisation, haemostasis, ablation, and coagulation of soft tissues.
The VYLO system offers a range of surgical capabilities, enabling precise incisions and the thorough removal of substantial soft tissue masses with accuracy and precision.
According to InnoVoyce, the system’s versatility is demonstrated by its FDA clearance across various medical specialities.
The system can be deployed in general surgery, gynaecology, gastroenterology, head, and neck/otorhinolaryngology (ENT), ophthalmology, neurosurgery, spinal surgery, plastic surgery, thoracic surgery, and urology.
InnoVoyce CEO Michael Davin said: “InnoVoyce was established with a mission to introduce innovative solutions to treat the millions of individuals affected by voice disorders.
“The FDA’s clearance of the VYLO Laser System marks a significant milestone in our commitment to advancing healthcare with scalable laser technologies.
“This system is not only pivotal for vocal health but is also designed to effectively treat a variety of mucosal tissue conditions, highlighting its broad applications in medical treatment.”
The VYLO Laser System combines the qualities of modern laser technologies within a single device for more precision and tissue specificity.
Using a rapid pulse setting, the system facilitates intricate procedures on smaller areas, while longer pulses accommodate broader and deeper targets.
The medical technology company said that this feature ensures optimal energy delivery, improving treatment effectiveness while safeguarding adjacent tissues from unintended damage.
Additionally, the blue light laser system has the patent pending FiberSafe technology.
FiberSafe is a safety mechanism designed to automatically transition the laser into standby mode in case of any flare-up along the fibre.
It also bolsters protection for patients and surgical teams by mitigating risks during operations and improving the reliability of the VYLO Laser System.
