Diowave Laser System, REF: Diowave 250W

Reason: Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.

Code information: UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81

Distribution pattern: US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.