JOULE 1064nm System and Accessories

The JOULE 1064nm System is a laser surgical instrument that delivers 1064 nanometer wavelength laser energy via a console with articulated arm delivery system and handpiece. It is intended for dermatological applications including treatment of vascular and pigmented lesions, hair removal, scar treatment, and facial wrinkles, as well as surgical applications including incision, excision, ablation, and coagulation/hemostasis across multiple surgical specialties.

The JOULE 1064nm System shares similar technological characteristics to predicate devices including Nd:Yag energy source, 1064 nm wavelength, 0.5-15 mm spot size, 5-60 Hz pulse repetition rate, 0.1-200 msec pulse duration, up to 140 J/cm² energy, 120 W power output, water-to-air cooling, microprocessor control, and footswitch activation. All specifications fall within the range of the predicate devices.

The device was tested to IEC 60601-1 (medical electrical equipment general requirements), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-2-22 (high frequency surgical equipment), and IEC 60825-1 (laser product safety). Biocompatibility testing and software verification/validation per FDA guidance were also conducted.

The JOULE 1064nm System is substantially equivalent to its predicates because it shares the same principles of operation (Nd:Yag laser delivery), identical technological characteristics within the predicate range, unchanged patient-contacting biocompatible components from the primary predicate, and demonstrated safety and effectiveness through bench testing, electrical/EMC compliance, and clinical effectiveness data showing 93% histological clearance rates for BCC comparable to reference devices.