Therapy US

The Therapy US is a handheld laser device indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. It consists of a handpiece with red (660 nm) and infrared (808 nm) laser diodes, a polycarbonate spacer for patient contact, and supporting accessories. The device is intended for use by doctors, nurses, and physical therapists.

The Therapy US uses diode lasers emitting at 660 nm (±10 nm) and 808 nm (±10 nm) with 100 mW optical power each. It features a larger spot size (82 mm²) compared to the predicate (1.16 mm²), resulting in significantly lower irradiance of 1.214 mW/mm² versus the predicate's 3.43-4.95 mW/mm². The device operates in continuous modulation mode and is powered by a 3.7V 2420 mAh lithium-ion battery.

IEC 60601-1 and IEC 60601-1-6 (electrical safety), IEC 60601-1-2:2014 + A1:2020 (electromagnetic compatibility), IEC 60601-2-22 and IEC 60825-1:2014 (laser safety), ISO 10993-1 (biocompatibility), and IEC/TR 60825-13:2011 (laser beam safety).

Both devices share product code NHN, Class II classification under 21 CFR 890.5500, and identical indications for neck and shoulder pain relief. While the subject device has higher total optical power, its substantially larger spot size results in lower irradiance (more conservative safety), and the predicate's significantly smaller beam area represents a more demanding safety condition. The identical operating principles, wavelengths, and indications, combined with equivalent or superior safety performance, demonstrate substantial equivalence.