Health Canada is warning Canadians about counterfeit laser hair removal devices used in some clinics that may “pose serious health risks.” In a public advisory, Health Canada lists the Soprano diode laser hair removal systems and diode laser therapy systems as an “unauthorized product.” “Do not buy or use unauthorized medical devices,” the safety alert states. “If purchased, immediately stop using and dispose of the product.” Counterfeit sold under ‘Soprano’ brand The counterfeit laser hair removal machines are being sold under the “Soprano” brand. The authentic Soprano devices are manufactured by Alma Lasers Ltd., whereas the label on the counterfeit version states it was manufactured by Beijing Perfectlaser Technology Co., Ltd. Health Canada says the counterfeit devices have been advertised and sold to clinics across the country. “Beijing Perfectlaser Technology Co., Ltd. has provided a falsified medical device licence and falsely represented the products as authorized medical devices,” the alert reads. “This may mislead purchasers into believing that the device has been authorized for sale and meet regulatory requirements when they do not.” It goes on the warn that counterfeit devices – which are illegal in Canada – are not the same as the authentic product and may pose “serious health risk due to their unknown safety and effectiveness.” What to do Health Canada is advising clinics who own a Soprano-branded hair removal machine, or may be looking to buy one, to verify the authenticity by checking the details on the permanent label. The label includes the manufacturer name, device name, and model or catalogue identifier. This information is also listed on the device licence in Health Canada’s Medical Devices Active Licence Listing. Those who do have a counterfeit product are told to immediately stop using it and dispose of it safely. If you’re not sure if the device is authentic or not, consult with the manufacturer. Patients are advised to see a licensed health-care professional if they have received laser therapy services and are experiencing health concerns like “immediate pain, reddening skin or swelling.” They should also report any product-related side effects or issues to Health Canada.
