Medical technology company InnoVoyce’s VYLO Laser System has received 510(k) clearance from the US Food and Drug Administration (FDA).
The VYLO Laser System, a 455nm blue light laser, is designed to offer up to 30W across four emission modes and is developed for surgical incision/excision, vaporisation and ablation.
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It is also intended for the haemostasis and coagulation of soft tissue, muscle, organs and glands.
Engineered for delivering a range of surgical capabilities, the VYLO Laser System allows everything from precise cuts to significant soft tissue mass removal.
With its efficacy and precision, the VYLO system is suitable for use in gynaecology, gastroenterology and otorhinolaryngology, as well as various surgical specialisms.
Blue light lasers of the system can emit beams between 400nm and 500nm. Their efficacy is demonstrated in soft tissue treatments, mainly in voice health (laryngology) and ear, nose, and throat (ENT) medicine.
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.”
Furthermore, the VYLO system features the patent-pending FiberSafe technology, which allows automatic shifting of the laser into standby mode if there is any flare-up along the fibre.
It is a critical safety feature, reduces operations risks and enhances the dependability of the VYLO Laser System.
