InnoVoyce Receives FDA 510(k) Clearance for VYLO™ 455nm Blue Light Laser System

Combining the best-in-class laser technologies for treating a broad range of mucosal tissue

BOSTON, MA., May 30, 2024 – InnoVoyce, a leading medical technology company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the VYLO™ Laser System. The VYLO Laser System is the first and only 455nm blue light laser to offer up to 30 watts of power and four emission modes. Intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The VYLO system is engineered to deliver a broad spectrum of surgical capabilities, enabling everything from the most delicate and precise cuts to the comprehensive removal of significant soft tissue masses with unmatched precision and control.

“InnoVoyce was established with a mission to introduce innovative solutions to treat the millions of individuals affected by voice disorders,” said InnoVoyce CEO Michael Davin. “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’s versatility is demonstrated by its FDA clearance across multiple medical specialties, making it an invaluable tool for a wide array of surgical procedures. Its precision and efficacy make it suitable for use in general surgery, gastroenterology, gynecology, head and neck/otorhinolaryngology (ENT), neurosurgery, ophthalmology, plastic surgery, spinal surgery, thoracic surgery, and urology. This broad range of applications positions the VYLO system as a transformative technology in the surgical landscape.

Blue light lasers emitting beams between 400nm and 500nm have demonstrated efficacy in soft tissue treatments, particularly in voice health (laryngology) and ear, nose, and throat (ENT) medicine. At 455nm, this wavelength is tailored for optimal absorption by hemoglobin, enabling precise targeting of blood vessels with minimal impact on surrounding tissues. This precision augments surgical interventions, promising enhanced outcomes for patients.

“Throughout my otolaryngology career, the potassium titanyl phosphate (KTP) and carbon dioxide (CO2) lasers have been the mainstays for laryngeal surgery,” said Lauren Tracy, MD, at Boston Medical Center (BMC). “The new VYLO Laser System with its 455nm blue light wavelength may change the landscape by combining the powerful cutting functionality of the CO2 laser with the angiolytic precision of the KTP laser. I’ve been very impressed with its versatility, power, and control. I am excited about the VYLO system advancing and enhancing our field and patient care.”

The VYLO Laser System combines the best attributes of contemporary laser technologies into a single device for unparalleled precision and tissue specificity. Leveraging its rapid pulse setting, it enables meticulous work on smaller areas, while longer pulses accommodate broader, deeper targets. This capability ensures optimal energy delivery, maximizing treatment efficacy while protecting surrounding tissues from unintended harm.

In addition to up to 30 watts of power and four emission modes, the VYLO system incorporates the patent pending FiberSafe™ technology, which automatically shifts the laser into standby mode in the event of any flare-up along the fiber. This critical safety feature enhances protection for patients and the surgical team by reducing risks during operations and increasing the dependability of the VYLO Laser System. To learn more about InnoVoyce and the VYLO Laser System, visit www.innovoyce.com.