RAPIDO ENT BLUE Laser System Receives FDA 510(k) Clearance for ENT Surgical Applications Across the United States

FDA clearance authorizes nationwide availability of RAPIDO ENT BLUE, a next-generation blue laser technology designed for precision ENT surgery

The device delivers enhanced surgical control, reduced thermal damage, and improved patient outcomes in otolaryngology procedures.

Medency, a leading medical device manufacturer specializing in surgical laser technologies, is pleased to announce that the RAPIDO ENT BLUE laser system has received FDA 510(k) clearance. This approval permits the device’s commercial distribution across the United States, representing a major milestone in the advancement of ENT surgical solutions.


Optimized for ENT Precision and Minimally Invasive Surgery

Engineered around the unique advantages of blue laser light, RAPIDO ENT BLUE enables fast, bloodless tissue vaporization and ablation, with minimal risk of necrosis or damage to surrounding tissue. The system offers significantly enhanced performance compared to conventional surgical techniques such as scalpels, electrosurgery, and alternative laser systems like KTP.


RAPIDO ENT BLUE: Clinical Benefits at a Glance

  • Hemostasis and bloodless tissue cutting
  • Minimized inflammation during recovery
  • Contact and non-contact treatment modes
  • Autoclavable optical fiber for maximum hygiene
  • Compact, wireless, and portable laser platform
  • Multiple pre-set clinical protocols
  • Range of sterile, single-use cannulas

Designed for Efficiency, Portability, and Surgical Safety

RAPIDO ENT BLUE is a portable ENT laser system that fulfills both clinical and operational demands across a variety of settings—from outpatient ENT clinics to hospital-based surgical environments. Its intuitive interface and wireless operation enable enhanced mobility and streamlined surgical workflow.


Leadership Statement

“Receiving FDA 510(k) clearance for RAPIDO ENT BLUE marks a significant achievement in our commitment to laser-based innovation for ENT professionals.” said Alessandro Boschi, CEO at Medency SRL. “This clearance allows us to expand access to safer, more effective surgical tools that support better outcomes for patients and providers alike.”


Contact Us

For product information, clinical inquiries, or to schedule a demonstration of RAPIDO ENT BLUE, please contact:

Marco Balestro
Clinical Advisor
info@medency.com
+39 0444 371462


About Medency

Medency is a global medical technology company focused on the development of advanced laser systems for surgical use. Our solutions empower healthcare professionals with tools that drive precision, patient safety, and procedural efficiency in specialties including ENT, dentistry, and general surgery.

Visit medency.com or follow us on LinkedIn at MEDENCY.