FDA WARNING_LETTER - Advance-Esthetic LLC - November 06, 2025

The FDA issued a Warning Letter to Advance-Esthetic LLC on August 25, 2026, following an inspection of its Fort Lauderdale facility from October 27 to November 6, 2025. The investigation determined that the company is marketing three medical devices—the Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro—without the required federal approval or clearance. Under the Federal Food, Drug, and Cosmetic Act, these products are considered adulterated and misbranded because the company failed to obtain premarket approval (PMA) or submit a 510(k) notification. The FDA noted that while the company listed these devices as exempt therapeutic massagers, they actually utilize radiofrequency and light-based technologies that exceed the technological limits of that classification. Furthermore, the marketing claims for these devices—such as cellulite reduction, collagen stimulation, and edema treatment—go beyond the medical purposes allowed for exempt massagers. Advance-Esthetic LLC must respond within 15 business days with a detailed plan to correct these violations and prevent their recurrence. Failure to comply may result in legal actions, including product seizures or financial penalties, and a follow-up inspection will be required to verify the company"s corrective measures.