FDA WARNING_LETTER - Neomedix Corporation

The FDA issued a Warning Letter to NeoMedix Corporation regarding its Trabectome High Frequency Generator/LP (K061258), citing the firm for marketing the device without proper marketing clearance or approval for its current intended use. The device was originally cleared for low power microsurgical applications, not for the treatment of glaucoma. However, FDA's review of the firm's website and training materials revealed promotion of the Trabectome for the "minimally invasive surgical management of glaucoma" and claims of "33% IOP Reduction on Average." These promotions constitute a major change or modification in the device's intended use, as per 21 CFR § 807.81(a)(3)(ii). Consequently, the Trabectome is deemed adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved PMA or IDE for its marketed use. It is also misbranded under section 502(o) of the Act for introducing a device with major intended use changes without submitting a new premarket notification (510(k)). NeoMedix Corporation is required to immediately cease activities resulting in misbranding or adulteration and provide a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable for implementation to avoid further regulatory actions such as seizure, injunction, or civil money penalties.