LED Light-Therapy Device Manufacturer Draws Warning From FDA

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

Vevazz LLC

• Issuing Office: Food and Drug Administration, Office of Medical Device and Radiological Health Operations
• Recipient: Jamie Fettig (owner)
• Date: Dec. 26 (posted Jan. 21)
• Inspection of facility in Eaton. Colo., June 3-20

Alleged Infractions Include:

• Marketed low level LED light-therapy devices without having application for premarket approval in effect or an approved application for an investigational device exemption.
• Made representations that created false impression devices had received FDA approval and that they were intended for unapproved uses.
• Made ...