FDA WARNING_LETTER - Led Dental Inc

The FDA issued a Warning Letter to LED Medical Diagnostics, Inc. / LED Dental, Inc. regarding their VELscope Vx device, citing violations of the Federal Food, Drug, and Cosmetic Act. The FDA determined the VELscope Vx is being marketed in the U.S. without marketing clearance or approval.

The device is deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption. It is also misbranded under section 502(o) for introducing the device into interstate commerce with major changes to its intended use without submitting a new premarket notification (510(k)).

The VELscope Vx was cleared under K102083 for use as an adjunct to traditional oral examination to enhance visualization of abnormalities and to help surgeons identify diseased tissue around lesions. However, the firm's website (www.leddental.com) promotes the device for "early detection of oral mucosal abnormalities," which constitutes a major change in intended use for which the firm lacks clearance or approval. Examples of promotional claims include "Detecting oral abnormalities early leads to more treatment options" and "identify oral mucosal abnormalities early — often months or even years before they can be identified with the unassisted eye."

LED Dental, Inc. is required to immediately cease activities resulting in the misbranding or adulteration of the VELscope Vx. The firm must