Vevazz Draws Warning Letter for Misbranding

Colorado-based Vevazz drew a warning letter from the FDA for misbranding two of its low-level LED light therapy devices, the Vevazz Contour and the Vevazz Bed, determining that both were adulterated because they didn’t have either an approved premarket approval application or investigational device exemption.

The agency deemed the Contour misbranded because the firm was marketing the product with significant changes to its use but failed to submit a new premarket notification. In addition, Vevazz misleadingly marketed the device on its website as officially approved.

The FDA said the company also falsely marketed the Vevazz Bed as approved or cleared and failed to notify the agency of its intentions to introduce the product into commercial distribution.