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FDA-Device2026-05-20Class IIPROCESSING DEFECT

Diowave 250W laser system needs software update for power output correction

Technological Medical Advancements
OTHERNationwide distribution

Diowave 250W laser system needs software update

Diowave 250W infrared laser systems used for temporary muscle and joint pain relief are operating at a maximum power output of 70W, which exceeds the FDA-cleared limit of 60W. A software update is required to correct the power output to the approved level.

  • Contact Technological Medical Advancements LLC if you own or operate a Diowave 250W laser system
  • Update your system software to version V1.81 or later
  • Do not use the device until the software update is applied
Hazard

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.

Sold states
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Affected count
16
Manufactured in
1601 Belvedere Rd Ste E-180, West Palm Beach, FL, United States
Products
Diowave Laser System, REF: Diowave 250W

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2026

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