Health Canada has issued a public warning about counterfeit laser equipment being marketed to Canadian clinics under the Soprano name, saying the unauthorised devices may pose significant risks to patients and healthcare providers.
The federal health regulator said on Friday, 18 September, that counterfeit diode laser hair-removal machines and therapy systems had been advertised and sold to clinics in Canada. The affected equipment carries the Soprano brand, while information on the devices identifies Beijing Perfectlaser Technology Co., Ltd. as the manufacturer.
Alma Lasers Ltd. manufactures the genuine Soprano systems. Health Canada reported that the legitimate manufacturer confirmed the devices identified in the advisory as counterfeit, not authentic Soprano products.
According to the regulator, the company associated with the counterfeit equipment supplied a falsified medical-device licence and presented the machines as authorised products. Such representations may give purchasers the impression that the equipment had undergone Canada’s regulatory review when it had not.
Health Canada stressed that counterfeit medical products may differ substantially from the genuine equipment they imitate. The lack of establishment of their safety, performance, and effectiveness through the appropriate regulatory process may expose patients to unknown hazards.
The agency is advising clinics to stop using the affected machines and dispose of counterfeit equipment safely. Businesses considering the purchase of medical devices are also being urged to verify the manufacturer’s name, device description and model or catalogue number against information contained in Health Canada’s Medical Devices Active Licence Listing.
Patients who have received laser treatment and subsequently experience immediate pain, skin redness or swelling may seek advice from a licensed healthcare professional.
The warning forms part of Canada’s broader efforts to prevent unauthorised medical equipment from entering or circulating in the domestic market. Health Canada says it works with the Canada Border Services Agency to help intercept non-compliant health products at the border.
Health Canada has also reminded consumers and healthcare businesses that counterfeit or unlicensed medical devices may contain inappropriate components, carry misleading labelling or fail to perform as expected.
