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Talk to a SpecialistTalk to a SpecialistTechnological Medical Advancements LLC manufactured the Diowave 100 WLS and Diowave 250 WLS laser systems without obtaining required FDA premarket approval (PMA) or investigational device exemption (IDE), rendering the devices adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. During an inspection conducted April 9-21, 2025, FDA investigators determined the company was distributing these medical laser devices for therapeutic use without proper regulatory authorization, as evidenced by marketing materials including physician brochures and operating manuals reviewed on the company's website. The violations centered on the company's failure to comply with premarket notification requirements and device classification regulations applicable to Class II or III medical devices.