Holmium Laser Therapeutic Apparatus (HZ-40)

The HZ-40 Holmium Laser Therapeutic Apparatus is a pulsed solid-state Holmium:YAG laser system operating at 2100 nm wavelength that delivers energy through optical fibers for surgical procedures. It is intended for use in open, laparoscopic, and endoscopic surgeries to perform incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, and stone fragmentation across multiple medical specialties including urology, gastroenterology, ENT, gynecology, and general surgery.

The device delivers 0.2-6 J per pulse at 30 Hz with a pulse duration of 90-2000 microseconds and maximum average power of 40W, operating on AC 100-240V power supply. It uses optical fiber delivery (SMA905-compatible), includes a touchscreen interface and single-pedal footswitch, and features an integrated liquid cooling system with safety features like emergency stop and door interlock. Key differences from predicates include a different power supply specification (AC 100-240V versus 400V 3-phase) and a safer Class 3R aiming beam, though specifications remain within or comparable to predicate ranges.

The device was tested and found compliant with IEC 60601-1:2005 + A1:2012 + A2:2020 (medical electrical equipment general safety), IEC 60601-1-2:2014 + A1:2020 (electromagnetic compatibility), IEC 60601-2-22:2019 (surgical laser equipment), IEC 60825-1:2014 (laser product safety), and IEC 62304:2006 + A1:2015 (medical device software lifecycle). Software validation also followed FDA guidance for premarket submissions of software in medical devices.

The HZ-40 has the same intended use and indications for use as the predicate devices (Litho DK30 and MultiPulse HoPlus), with identical regulatory classification (Class II, product code GEX) and laser wavelength (2100 nm). Minor differences in pulse duration, frequency, average power, and power supply are within acceptable ranges demonstrated by predicate devices and do not raise new safety or effectiveness concerns, as confirmed by compliance with applicable IEC standards.