FDA WARNING_LETTER - Technological Medical Advancements LLC - April 21, 2025

The FDA issued a Warning Letter to Technological Medical Advancements LLC on September 26, 2025, following an inspection from April 9-21, 2025, in West Palm Beach, Florida. The letter addresses significant violations concerning the company"s Diowave 250 WLS and Diowave 100 WLS laser systems, which the FDA classified as adulterated and misbranded medical devices under the Federal Food, Drug, and Cosmetic Act.

Specifically, the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for these devices as currently marketed, and failed to submit a 510(k) premarket notification. The FDA found that the Diowave systems employ "stealth micro-pulse laser technology" that inhibits heat, fundamentally differing from the "Infrared Lamp" classification (21 CFR 890.5500) under which the firm had previous clearance, which requires topical heating.

Furthermore, Technological Medical Advancements LLC markets these devices for an expanded range of intended uses far beyond their cleared indications for temporary pain relief and increased local blood circulation. New claims include treating conditions like peripheral neuropathy, abdominal and pelvic pain, wound care, and stimulating tissue growth, which the FDA considers major changes requiring new premarket submissions. The FDA requires the company to address these violations by obtaining proper marketing authorization for the devices as they are currently manufactured and promoted.