Therapy EC, Therapy XT

Therapy EC and Therapy XT are non-heating infrared laser devices indicated for adjunctive use in temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. They consist of an ergonomic handpiece with one 808 nm infrared laser diode, optical fibers, battery, and polycarbonate spacers that maintain safe distance from the patient's skin during treatment.

The subject devices use a single 808 nm diode laser emitting 100 mW per emitter, compared to the predicate's three 830 nm GaAlAs diodes delivering 90 mW total. Both use semiconductor diode laser technology operating on the principle of luminous energy absorption. The wavelength difference (808 vs 830 nm) is justified by similar absorption coefficients in melanin, hemoglobin, and water; the power difference (100 vs 90 mW) falls within the 20% tolerance specified in IEC 60601-2-22.

IEC 60825-1 (laser safety classification), IEC 60601-1 (electrical equipment safety), IEC 60601-2-22 (medical laser equipment safety and performance), IEC 62304 (medical device software lifecycle), and ISO 10993-1 (biological evaluation of medical devices).

The subject device shares identical indications for use, intended use, and operating principle (light emission via diode laser) with the predicate. Technological differences in wavelength and optical power do not raise new safety or effectiveness concerns because absorption characteristics are similar at both wavelengths and the power difference is within established tolerances. Nonclinical testing demonstrates compliance with applicable safety standards, establishing substantial equivalence without requiring clinical data.