Technological Medical Advancements LLC recalls Diowave Laser System

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.

Starting on 1/9/2026, customer notifications were sent informing customers to install software update V1.81. On 3/11/2026, correction notices were sent to customers informing them to take the following actions: 1) Install Software Update V1.81. Follow the WiFi upgrade instructions to complete the update. The update is free of charge and requires no hardware modifications. 2) Confirm Completion. Once the update is installed, please complete and return the enclosed Correction Response Form by email to info@diowavelaser.com. Alternatively, mail the completed form to TMA at the address above. 3) Forward This Notice. This notice must be passed on to all persons within your organization who need to be aware of this correction, and to any organization where the affected device has been transferred or is currently in use. 4) Contact Support If Needed. Firm's technical support team is available Monday through Friday, 9:00 AM 5:00 PM ET, at (561) 722-1153 or info@diowavelaser.com

• FDA enforcement recordOfficial FDA database entry for Z-2162-2026
• FDA 510(k) clearance · K121363The device's official FDA premarket clearance record
• FDA device classification · ILYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 890.5500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Technological Medical Advancements LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.