FDA WARNING_LETTER - LEEL Tech - August 28, 2024

The FDA issued a Warning Letter to Xiong Li and Yan Gao, associated with LEEL Tech, for offering unapproved and uncleared medical devices for sale in the United States. The firm's products, including CLYN (CZ001& CLYN Universal), LEEL, and SOLID (Solid CPAP & ONECLICK SOLID) CPAP cleaners, are marketed on http://leelpro.com as using activated oxygen (ozone) to disinfect CPAP therapy devices and accessories. The FDA determined these products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The devices are adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved premarket approval (PMA) application (section 515(a)) or an investigational device exemption (IDE) (section 520(g)). They are also misbranded under section 502(o) of the Act for being commercially distributed without the required premarket notification (510(k)) as per 21 CFR 807.81(a). Furthermore, the firm's actions of importing and distributing these adulterated and misbranded devices constitute prohibited acts under section 301 of the FD&C Act.

Despite a prior FDA letter and the firm's inadequate response claiming to be an "agent" and planning to sell remaining inventory, the FDA requires the firm to cease all activities resulting in misbranding or adulteration. A written response is mandated within fifteen business days, detailing specific corrective actions, supporting documentation, and a timetable to prevent recurrence. Failure to comply may result in further regulatory action.