Aesthetics Systems Usa Inc – FDA Warning Letter

The FDA issued a Warning Letter to Aesthetics Systems USA, Inc., an initial importer and exclusive distributor, for marketing six aesthetic devices (Vitapeel, Vitaderm, Vitalift, Angie Thermocoagulation System, Vitalymph, and Vital-Ultra Systems) in the U.S. without required marketing clearance or approval. The devices are deemed adulterated under section 501(f)(1)(B) of the Act due to the absence of approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) applications. They are also misbranded under section 502(o) for being introduced into interstate commerce with major changes/modifications to their intended use without submitting new premarket notifications (510(k)), as required by section 510(k) and 21 CFR 807.81(a)(3)(ii).

For each device, the FDA found that marketed intended uses differed significantly from those of legally marketed devices in their classifications (e.g., 21 CFR 878.4820, 21 CFR 890.5660, 21 CFR 890.5765), exceeding exemption limitations and necessitating 510(k) submissions. The Angie Thermocoagulation System was marketed with new intended uses beyond its cleared 510(k). Furthermore, Aesthetics Systems USA, Inc., failed to register its establishment with the FDA as an initial importer under 21 CFR 807.20(a), resulting in additional misbranding under Section 502(o).

The FDA demands immediate cessation of activities causing device misbranding or adulteration. The firm must respond within fifteen business days with specific corrective actions, documentation, and a timetable for systemic problem resolution. Non-compliance may lead to regulatory actions like seizure, injunction, civil money penalties, and refusal of admission for Dectro International products into the U.S.