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Laser-based medical devices not authorized to treat fungal nail infections
- Starting date:
- July 25, 2019
- Type of communication:
- Information Update
- Medical Device
- Source of recall:
- Health Canada
- Medical Devices
- General Public, Healthcare Professionals
- Identification number:
For immediate release
OTTAWA – Health Canada is advising Canadians that laser-based medical devices are not authorized to treat fungal nail infections (onychomycosis).
Health Canada is aware that certain clinics, spas, and vendors are promoting laser-based medical devices to treat fungal nail infections. Canadians may be putting their health at risk if they rely on laser-based treatments instead of seeking medical attention to treat these infections.
Before receiving any treatment for a fungal nail infection, Canadians should seek the advice of a health care professional who can diagnose the infection and recommend an effective course of treatment. An incorrect diagnosis may result in unnecessary and inappropriate treatments.
A fungal nail infection may cause pain, damage to or loss of nails, and skin infections. Some patients, such as those with diabetes or weakened immune systems, may be at greater risk of developing serious complications, including bacterial skin infections and conditions that threaten the limbs.
Some laser-based medical devices are licensed in Canada to temporarily increase the clarity of the nail in patients with a fungal nail infection. These devices will only change the appearance of the nail and will have no impact on treating the underlying infection. Health Canada has not received enough evidence to support claims that laser treatments could be used to treat a fungal nail infection.
To safeguard the safety of Canadians, Health Canada is working with manufacturers, distributors, vendors, and importers that sell medical devices to ensure that they are compliant with all relevant regulations.
What you should do
- Do not use laser-based medical devices to treat fungal nail infections.
- Be cautious of clinics, spas or vendors advertising laser-based medical devices to treat fungal nail infections.
- Patients who have only used laser-based medical devices to treat fungal nail infections should contact their health care professional immediately.
- Check Health Canada’s Recalls and Safety Alerts database for advisories on illegal health products that have been found on the Canadian market.
- Report complaints involving medical devices, including the advertising and sale of unauthorized devices, to Health Canada.
- Stay connected with Health Canada and receive the latest advisories and product recalls.
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