Health Canada clarification: laser-based medical devices are not licensed in Canada to cure fungal nail infections
- Starting date:
- July 25, 2019
- Posting date:
- December 5, 2019
- Type of communication:
- Information Update
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals
- Identification number:
- RA-70553
Last updated: 2019-12-05
Update: December 5, 2019
Health Canada is issuing this update to clarify its position on laser-based medical devices. Earlier this year, Health Canada issued an Information Update (see below) advising Canadians that laser-based medical devices are not authorized to treat fungal nail infections (onychomycosis). Health Canada is clarifying that, while some laser-based medical devices are licensed in Canada to temporarily increase the clarity of the nail in patients with a fungal nail infection, none have been licensed to cure these infections.
Canadians who have received laser treatments for their condition from anyone other than a health care professional, or who have been told that laser-based medical devices would cure their fungal nail infection, should contact their health care professional in case further treatment is required.
Health Canada is aware that, following its initial communication in July 2019, some provincial regulatory bodies requested that their members stop using these devices. Since the practice of medicine falls under provincial and territorial jurisdiction, Health Canada recommends that health care professionals contact their provincial or territorial regulatory body if they have any questions regarding the use of these devices in their province or territory.
Original Information Update: July 25, 2019 - Laser-based medical devices not authorized to treat fungal nail infections
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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