FDAHealthJanuary 9, 2026
Technological Medical Advancements LLC — Diowave Laser System, REF: Diowave 250W
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 9, 2026
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
What's affected?
- Product
- Diowave Laser System, REF: Diowave 250W
- Lot code
- UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Additional details
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 16.
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