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Laser hair removal systems and therapy devices sold illegally by a company in China are being recalled in Canada.
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Diode laser hair removal systems and diode laser therapy systems sold under the “Soprano” brand by Beijing-based Perfectlaser Technology Co., Ltd. have been deemed “counterfeit” by Health Canada.
“These counterfeit devices have been advertised and sold to clinics in Canada,” the agency stated in a notice issued on Friday.
“Information on the label of the counterfeit product indicates the device is manufactured by Beijing Perfectlaser Technology Co., Ltd.,” Health Canada added, clarifying that “authentic” Soprano devices are actually manufactured by Alma Lasers Ltd. out of Israel.
It went on to note that Beijing Perfectlaser Technology Co., Ltd. “provided a falsified medical device licence and falsely represented the products as authorized medical devices.”
What patients should do
Patients or clients who have received laser therapy services and have health concerns, including immediate pain, reddening skin, or swelling, should consult a licenced health-care professional.
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Anyone with any health product-related side effects or complaints is also asked to report to Health Canada.
What clinics should do
The federal health agency noted that purchasers may have been misled into believing the device has been authorized for sale and meets regulatory requirements — but they do not.
“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,” officials warned.
“The sale of counterfeit health products is illegal in Canada.”
Clinics with laser hair removal machines and/or therapy systems from the Soprano brand with a permanent label bearing “Perfectlaser” are advised to compare it with the corresponding information listed on the device licence in Health Canada’s Medical Devices Active Licence Listing website.
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For clinics that are unsure, consult with the manufacturer about a product’s authenticity.
Clinics that have the counterfeit product should immediately stop using it and safely dispose of the device.
If you have additional questions or concerns, call: 1-866 225-0709 or email hcinfo.infosc@canada.ca.
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