Leonardo Duster

The Leonardo® Duster is a 60W Thulium fiber laser operating at 1940nm wavelength used for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue. It can be used with or without an endoscope across urology (including lithotripsy, BPH ablation, prostate procedures), gastroenterology, and gynecological surgery. The device operates in continuous or pulsed modes with user-friendly touchscreen control.

The Leonardo® Duster shares identical indications for use, same laser type (Thulium), same wavelength (1940nm), same power output (60W), same operation modes (pulsed and continuous wave), and same cooling system (air cooling) as the predicate SOLTIVE™ system. Minor differences include pulse length range of 0.04-50ms versus 0.2-50ms, aiming beam power of ≤3mW versus ≤5mW, and slightly heavier weight (41kg versus 33kg).

Compliance verified against 21 CFR 1040, EN 1041:2008, ISO 14971:2019, IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-22:2007, IEC 60825-1:2007, IEC 62366-1:2015, ISO 10993 series for biocompatibility, and ISO 11135:2014 for sterilization. Software validation followed FDA guidance on device software functions.

Substantial equivalence is established through identical indications for use, identical technological platform (Thulium fiber laser at 1940nm), same power and operating modes, and comparable performance characteristics. The minor differences in pulse duration range and aiming beam power do not impact safety or effectiveness since bench and standards testing confirm the device performs equivalently to the predicate for all intended applications.