Overview
- ANMAT issued Disposición 5172/2026 on Thursday prohibiting the use, sale, distribution and online publication of the Alma Lasers Soprano ICE unit with serial SN S12ICE2382.
- The action followed a complaint from Sirex Médica S.A., the registered sole importer, which said the manufacturer recorded that the serialized unit was sold to Portugal in 2018 suggesting an irregular entry into Argentina.
- Inspectors searched Modelarte Medicina Estética in Rosario but did not find the specific Soprano ICE; they did find three other devices without sanitary authorization at that address.
- Because the device’s current location and provenance remain unestablished, ANMAT referred the case to its Coordinación de Asuntos Judiciales and notified health and consumer authorities as a preventive safety measure.
- The regulator described the Soprano ICE as a class III diode-matrix laser used for photothermolysis at wavelengths near 755/810 nm, and warned that use of an uncertified unit could harm patients and operators.