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Technological Medical Advancements LLC: Diowave Laser System, REF: Diowave 250W

Medical DevicesSource: FDA (device) · Date: 2026-05-20

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Technological Medical Advancements LLC
Product
Diowave Laser System, REF: Diowave 250W
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Recall initiated
2026-01-09
Code info
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Product quantity
16
Voluntary mandated
Voluntary: Firm initiated
City
West Palm Beach
State
FL
Country
United States
Event id
98507
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