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

Friday, May 31, 2024

InnoVoyce, a leading medical technology company, has recently received FDA 510(k) clearance for its latest innovation, the VYLO™ Laser System.

This system, the first of its kind, emits 455nm blue light and offers up to 30 watts of power along with four emission modes. It is intended for various surgical purposes including incision, vaporization, ablation, hemostasis, and coagulation of soft tissues such as skin, muscle, cartilage, and organs.

"The FDA's clearance of the VYLO Laser System is a significant milestone in our mission to introduce innovative solutions for voice disorders and beyond.

This system not only benefits vocal health but also extends to treating various mucosal tissue conditions, showcasing its broad medical applications."

The versatility of the VYLO Laser System is evident from its FDA clearance across multiple medical specialties, making it an essential tool for a wide range of surgical procedures.

Its precision and efficacy make it suitable for use in fields including general surgery, gastroenterology, gynecology, ENT, neurosurgery, ophthalmology, plastic surgery, spinal surgery, thoracic surgery, and urology, positioning it as a transformative technology in the surgical landscape.

Blue light lasers in the 400nm to 500nm range have demonstrated effectiveness in treating soft tissue, particularly in laryngology and ENT medicine.

The 455nm wavelength of the VYLO Laser System is tailored for optimal absorption by hemoglobin, allowing precise targeting of blood vessels with minimal impact on surrounding tissues, thereby promising improved outcomes for patients undergoing surgical interventions.

The potential of the VYLO Laser System to revolutionize laryngeal surgery. "Its versatility, power, and control are impressive," she stated, "combining the cutting functionality of the CO2 laser with the angiolytic precision of the KTP laser."

The VYLO Laser System combines the strengths of contemporary laser technologies into a single device, offering unparalleled precision and tissue specificity.

Its rapid pulse setting enables meticulous work on smaller areas, while longer pulses accommodate broader, deeper targets, ensuring optimal energy delivery and treatment efficacy while safeguarding surrounding tissues.

The VYLO system incorporates FiberSafe™ technology, a patent-pending feature that automatically shifts the laser into standby mode in the event of a flare-up along the fiber, enhancing safety during operations and increasing the system's dependability.


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