FDA WARNING_LETTER - Silkprousa LLC - September 15, 2020

The FDA issued a Warning Letter to Marilyn Dans regarding the firm's marketing of "Pink Luminous Breast," a breast transilluminator, in the United States without required marketing clearance or approval. The device is intended for breast evaluation, including detecting abnormalities and potentially harmful tissue, and is classified as a Class III device (21 CFR 892.1990), requiring an approved Premarket Approval (PMA) application.

The device is adulterated under section 501(f)(1)(B) of the Act because no approved PMA or investigational device exemption is in effect. It is also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Labeling on the package and website includes claims such as "FDA registered medical screening tool" and "FDA approved and cleared for safety," and uses the FDA logo, which is prohibited and misleading, constituting misbranding under section 502(a). An FDA search found no registration or listing for the firm or device.

Due to these violations, Pink Luminous Breast devices are subject to refusal of admission into the U.S. ("detention without physical examination"). The firm must take prompt action to correct all violations, including addressing systemic problems, and provide a written response within fifteen business days detailing corrective actions, a timetable for implementation, and documentation. Failure to comply may result in further regulatory actions, including seizure, injunction