Summary: InnoVoyce has received FDA 510(k) clearance for the VYLO Laser System, the first 455nm blue light laser offering up to 30 watts of power. This system is designed for various soft tissue surgical procedures, with features ensuring precision and safety.

Key Takeaways:

  • Innovative Laser Technology: The system offers up to 30 watts of power and four emission modes for precise soft tissue surgeries.
  • Safety and Precision: Features like FiberSafe technology enhance safety during operations.
  • InnoVoyce VYLO Laser System Receives FDA Clearance

InnoVoyce has received U.S. 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.

Versatile Surgical Applications

The VYLO Laser System is 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. It 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 Michael Davin, InnoVoyce CEO. “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.”

Optimal Surgical Outcomes

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.

Advanced Features and Safety

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.