Canada
Diode laser hair removal and diode laser therapy systems sold under the “Soprano” brand that list Beijing Perfectlaser Technology Co., Ltd as the manufacturer on the permanent label (authentic Soprano devices are made by Alma Lasers Ltd) are affected. Health Canada says these are counterfeit, supported by a falsified medical device licence, not authorized and may pose serious health risks due to unknown safety and effectiveness. Clinics should verify label details against Health Canada’s Medical Devices Active Licence Listing and stop using and safely dispose of counterfeit devices; patients with pain, skin reddening or swelling should consult a licensed healthcare professional and report side effects to Health Canada.
How to identify it
Diode laser hair removal systems and diode laser therapy systems from Beijing Perfectlaser Technology Co., Ltd
The hazard
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 to 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 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.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)