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ANMAT bans illegal Alma Lasers hair removal device in Argentina
Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued an immediate ban on the use, sale, and distribution of a specific laser hair removal device across the country.
The prohibited product is identified as the ‘Cabezal 810nm 2cm Speed de Soprano ICE original’ from the company Alma Lasers, specifically serial number ICE122001380, manufactured in February 2016. The ban follows an investigation into irregularities regarding the device's origin and traceability.
Sirex Médica S. A., the exclusive importer for the brand in Argentina, initiated the complaint after discovering the unit was not in their local databases. Alma Lasers subsequently confirmed that the specific head was originally produced and intended for the United States market and entered Argentina irregularly. Because the device's storage and handling conditions cannot be verified, ANMAT warned that it lacks safety and effectiveness guarantees, posing risks such as burns or skin damage.