FDA OKs InnoVoyce’s VYLO 455nm Blue Light Laser

InnoVoyce has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its VYLO laser system.
 
VYLO, according to the Boston-based company, is the first, only 455 nm blue light laser that offers up to 30 watts of power and four emission modes. It’s used for 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.
 
InnoVoyce said the laser system’s versatility makes it an invaluable tool for general surgery, gastroenterology, gynecology, head and neck/otorhinolaryngology (ENT), neurosurgery, ophthalmology, plastic surgery, spinal surgery, thoracic surgery, and urology.
 
Blue light lasers emitting beams between 400 nm and 500 nm have shown efficacy in soft tissue treatments, particularly in laryngology and ENT medicine. At 455 nm, this wavelength is tailored for optimal absorption by hemoglobin, enabling precise targeting of blood vessels with minimal impact on nearby tissues.
 
VYLO’s rapid pulse setting enables meticulous work on smaller areas. Longer pulses accommodate broader, deeper targets. The system features FiberSafe technology that automatically shifts the laser into standby mode should a flare-up along the fiber occur.
 
“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 CO 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.”
 
“InnoVoyce was established with a mission to introduce innovative solutions to treat the millions of individuals affected by voice disorders,” added 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.”