AuroLase® System

The AuroLase System is a portable, cart-based laser surgical instrument that delivers 1-9 watts of continuous-wave near-infrared (810 nm) radiation through flexible optical fibers to ablate, incise, excise, coagulate, and vaporize soft tissues. It incorporates a dual-channel diode laser, a control unit with coolant pump and flow sensors, and can deploy one or two fibers simultaneously while providing liquid saline coolant to moderate fiber temperature. It is intended for use in open and endoscopic surgical procedures across multiple specialties including general surgery, ophthalmology, urology, dermatology, and others.

The subject device uses a diode laser at 810±10 nm wavelength with 1-9 W power output per fiber (up to 18 W total), operates in continuous-wave mode, includes fiber cooling with saline coolant at 0-12 mL/min per channel, and can deploy 1-2 fibers with 10/20/30 mm isotropic applicator lengths. The predicate device (Diomed Delta 15) operates at 810±20 nm with ≤15 W total power, has no fiber cooling, and deploys a single fiber with 10 mm or end-firing configuration. Both devices use 650 nm aiming beams.

IEC 60601-1:2005/A1:2012 (Medical Electrical Equipment—General Requirements for Basic Safety and Essential Performance), IEC 60601-1-2:2014 (Electromagnetic Compatibility), Software Validation & Verification Testing, and Bench Testing to verify performance specifications.

The subject and predicate devices share the same intended indications for use (soft tissue ablation in surgical procedures) and employ substantially equivalent technology: both use 810 nm diode lasers for photothermal ablation via optical fibers with comparable aiming beams. While the subject device offers enhanced features (dual-channel capability, fiber cooling, higher maximum power), these technological differences do not raise different questions of safety and effectiveness because they represent incremental improvements to an established device category rather than fundamental changes to the mechanism of action or clinical application. Non-clinical testing demonstrates design compliance and substantial equivalence to the predicate.