Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)

The Holmium Laser Therapeutic Apparatus (HZ-A, HZ-B, HZ-E) is a pulsed solid-state holmium:YAG laser system that delivers energy at 2100 nm wavelength through optical fibers for soft tissue surgery and stone fragmentation. It is intended for use in surgical procedures including incision, excision, resection, ablation, vaporization, coagulation, and hemostasis across specialties such as urology, gastroenterology, ENT, gynecology, and general surgery.

The subject device operates at 2100 nm with pulsed emission, pulse duration of 90–1000 microseconds, energy per pulse up to 4.5–5.0 joules depending on model, and frequency up to 40–60 Hz. The predicate device (Litho 150/Cyber Ho 150) has similar specifications but with slightly higher maximum average power (152W vs. 80–90W for subject models) and aiming beam power (< 5 mW vs. < 3 mW). Both use optical fiber delivery and diode-pumped Ho:YAG laser technology.

Electrical safety and electromagnetic compatibility were tested against IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-22:2019, and IEC 60825-1:2014. Software development and validation followed IEC 62304:2006 and FDA Guidance for Software Contained in Medical Devices.

The HZ Series shares the same intended use, laser wavelength, emission type, delivery system, and regulatory classification (Class II, 21 CFR 878.4810) as the predicate device. Minor differences in pulse duration, energy per pulse, frequency, and aiming beam power do not raise new safety or effectiveness questions. The devices employ fundamentally identical technological principles, making the subject device substantially equivalent to the predicate.