Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The AuroLase System is intended for use in delivering up to 9 Watts of continuous wave radiation to a flexible optical fiber for use in ablation, incision, excision, coagulation and vaporization of soft tissues in open and endoscopic surgical procedures including in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedic.
The AuroLase System is intended for use in delivering up to 9 Watts of continuous wave radiation to a flexible optical fiber for use in ablation, incision, excision, coagulation and vaporization of soft tissues in open and endoscopic surgical procedures including in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedic.
The AuroLase® System (AS) is a portable, cart-based integrated liquid cooled laser system for use in professional healthcare facilities. The AuroLase System is used to generate photothermal ablation of selected soft tissues using 1-9W of near infrared optical power via 1 or 2 optical fibers either individually or simultaneously while providing liquid coolant to moderate the temperature at the fiber surface. The laser is delivered to the tissue of interest via an optical fiber system, the Nanospectra Laser Delivery Device (LDD), cleared via K202953. It is for prescription use only. Central to the AuroLase System is the AuroLase Laser Device (ALD), a dual channel, continuous-wave, class IV GaAs diode laser that provides the optical energy used to excite soft tissues to ablative temperatures. The ALD incorporates an integrating sphere power meter (optometer) which is used to adjust the laser output that is delivered to the patient to the power shown on the display. Enabling the ALD's functionality is the AuroLase Control Unit (ACU) which incorporates: a peristaltic pump for providing sterile coolant to the Laser Delivery Devices, dual ultrasonic sensors to assure that coolant flows through the LDDs, a footswitch to control laser activation, temperature monitors for up to two optional external thermocouples, and a software application that controls, integrates, and monitors these functions. The AS is designed and tested for operation in a professional healthcare facility.
Summary parsed at:2026-06-01 05:21:49 UTC
