FDA Enforcement
Class II
Ongoing
Diowave Laser System, REF: Diowave 250W
Recall: Z-2162-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2162-2026
- Event ID
- 98507
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Technological Medical Advancements LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2026
- Initiation Date
- January 9, 2026
- Classification Date
- May 11, 2026
- Address
- 1601 Belvedere Rd Ste E-180, West Palm Beach, FL, 33406-1541, United States
Description
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 Info
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Distribution
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Quantity
16