FDA WARNING_LETTER - Vevazz LLC - June 20, 2019

The FDA issued a Warning Letter to Vevazz, LLC following a June 2019 inspection, identifying significant violations for their low-level LED light therapy devices, including the Vevazz Contour, Vevazz Bed, and Face Mask.

The Contour and Bed were deemed adulterated for lacking approved premarket approval (PMA) or investigational device exemption (IDE) applications. The Contour was also misbranded due to significant, uncleared changes to its intended use (e.g., treating neuropathy, inflammation, cellulite, scars, wrinkles, skin tightening) and design (e.g., added wavelengths, increased LEDs/paddles), and for misleading representations of FDA approval. The Bed and Face Mask were misbranded for not submitting premarket notifications (510(k)).

The inspection also revealed numerous Quality System regulation (21 CFR Part 820) violations, including: - Lack of established procedures for complaint handling, design control (including risk analysis), purchasing/supplier management, finished device acceptance, equipment calibration, nonconforming product control, and corrective and preventive actions (CAPA). - Failure to maintain a Device Master Record (DMR) and Device History Record (DHR). - Inadequate training procedures and records. - Absence of quality audits and management reviews of the quality system. - Failure to implement written Medical Device Reporting (MDR) procedures (21 CFR Part 803).

Vev