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U.S. Department of Health and Human Services

Class 2 Device Recall Diowave 250W Laser System (250WLS), Diowave Laser System Diowave Stealth Max

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 Class 2 Device Recall Diowave 250W Laser System (250WLS), Diowave Laser System Diowave Stealth Maxsee related information
Date Initiated by FirmJanuary 09, 2026
Date PostedMay 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2162-2026
Recall Event ID 98507
510(K)NumberK121363 
Product Classification Lamp, infrared, therapeutic heating - Product Code ILY
ProductDiowave Laser System, REF: Diowave 250W
Code Information UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
FEI Number 3009346095
Recalling Firm/
Manufacturer		 Technological Medical Advancements LLC
1601 Belvedere Rd Ste E-180
West Palm Beach FL 33406-1541
For Additional Information Contact
866-862-6606
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionStarting 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
Quantity in Commerce16
DistributionUS Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ILY
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