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[HEALTH] · Argentina · 2 sources

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ANMAT bans Alma Lasers hair removal device in Argentina

Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has banned the sale, use, and distribution of an Alma Lasers Soprano Ice laser hair removal device across the country due to commercial irregularities.

The ban follows a complaint from Sirex Médica S. A., the official importer of Alma Lasers technology in Argentina. Investigations revealed that the specific unit involved (serial number SN S12ICE2382) was originally sold to Portugal in 2018 and was never legally imported into Argentina.

ANMAT coordinated an inspection at the Modelarte Medicina Estética S. R. L. center in Rosario, Santa Fe, where the device was allegedly in operation. The regulatory body warned that using such medical devices without proper sanitary control or calibration poses significant risks of burns and injuries to both patients and operators.

Entities

ANMAT · Alma Lasers · Modelarte Medicina Estética S. R. L. · Sirex Médica S. A.