Counterfeit laser hair removal and therapy devices found in some clinics and may pose serious health risks

Issue

Health Canada is advising Canadians about counterfeit laser hair removal machines and therapy systems sold under the “Soprano” brand. The authentic Soprano devices are manufactured by Alma Lasers Ltd. Information on label of the counterfeit product indicates the device is manufactured by Beijing Perfectlaser Technology Co., Ltd. These counterfeit devices have been advertised and sold to clinics in Canada. Beijing Perfectlaser Technology Co., Ltd. has provided a falsified medical device licence and falsely represented the products as authorized medical devices. This may mislead purchasers into believing that the device has been authorized for sale and meet regulatory requirements when they do not. The manufacturer of the authentic device confirmed that these devices manufactured by Beijing Perfectlaser Technology Co., Ltd are counterfeit. Counterfeit health products are imitations of authentic products but are not the same and may pose serious health risk due to their unknown safety and effectiveness. The sale of counterfeit health products is illegal in Canada. Health Canada protects public health and safety when companies are found to be selling unauthorized health products in Canada, including by warning Canadians when needed. The Department also works with the Canada Border Services Agency to help prevent the import of any unauthorized health products.

What you should do

• If you are a clinic: If you have a laser hair removal machine and therapy system bearing the “Soprano” brand or before purchasing any medical device, verify the device’s authenticity by comparing the information on the permanent label, including the manufacturer name, device name, and model or catalogue identifier with the corresponding information listed on the device license in Health Canada’s Medical Devices Active Licence Listing. If you have counterfeit product, immediately stop using and safely dispose of the device. Consult with the manufacturer if you are unsure whether a device is authentic.
• If you have a laser hair removal machine and therapy system bearing the “Soprano” brand or before purchasing any medical device, verify the device’s authenticity by comparing the information on the permanent label, including the manufacturer name, device name, and model or catalogue identifier with the corresponding information listed on the device license in Health Canada’s Medical Devices Active Licence Listing.
• If you have counterfeit product, immediately stop using and safely dispose of the device.
• Consult with the manufacturer if you are unsure whether a device is authentic.
• If you are a patient: Consult a licensed healthcare professional if you have received laser therapy services and have health concerns including immediate pain, skin reddening or swelling. Learn more : Cosmetic Laser Treatments Report any health product-related side effects or complaints to Health Canada.
• Consult a licensed healthcare professional if you have received laser therapy services and have health concerns including immediate pain, skin reddening or swelling. Learn more : Cosmetic Laser Treatments
• Report any health product-related side effects or complaints to Health Canada.