Diowave 250W laser system needs software update for power output correction
What this means
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
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2026Want us to check the next one for you?
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