Overview
- Disposición 7044/2025, published in the Boletín Oficial, prohibits the use, distribution and sale of the device identified as “SOPRANO TITANIUM – ALMA – SN MNLTEMS12212202-01.”
- DEYGMPS inspectors found the laser in a beauty center with no manufacturer or importer data and no documentation establishing its origin.
- Sirex Médica S.A., the authorized importer of Alma Soprano Titanium, verified the inspected unit was not among its authentic imports or distributions.
- ANMAT cited visible anomalies versus genuine devices, including a black front panel instead of steel gray, rectilinear rear edges, missing labels, and an invalid serial/barcode.
- The agency ordered market removals, notified provincial and CABA health authorities, warned of risks to patients and operators, urged professionals not to acquire such devices, and said inspections will continue.