Health Canada



Health Canada

December 05, 2013 14:17 ET

Unlicenced Laser Hair Removal Products May Cause Eye Damage

OTTAWA, ONTARIO--(Marketwired - Dec. 5, 2013) - Health Canada testing has identified unlicenced medical devices (see below) being sold on the Internet for hair removal that may pose a serious risk to health, including significant eye damage and blindness.

These devices have the potential to cause serious harm due to the intensity of the radiation they emit and the lack of sufficient safety features. Momentary exposure to a direct or reflected beam -- even for a fraction of a second -- may cause permanent eye damage and serious burns.

Health Canada regulates laser and intense pulsed light devices under the Radiation Emitting Devices Act, the Medical Devices Regulations and the Food and Drugs Act. These types of products must be assessed for safety and effectiveness when used for their licenced medical purposes and according to the manufacturers' directions before they are authorized for sale in Canada.

The use of unlicenced lasers or intense pulsed light devices may harm your health as they have not been assessed against Health Canada's requirements for safety, effectiveness and quality. Medical devices that have been licenced for sale in Canada can be found on Health Canada's searchable Medical Devices Active Licence Listing (MDALL) database. Searches can be conducted by company, licence or device.

Canadians may also wish to consult Health Canada's It's Your Health article regarding the safe use of cosmetic laser treatments before using these types of products.

Consumers who have health concerns related to the use of these devices should speak with their healthcare professional. Health Canada would also like to remind Canadians that while many websites that sell medical devices are lawful businesses that provide a useful service, others sell devices that may pose serious health risks.

It is important to note that these devices may also be sold on sites not on the list below. Canadians are encouraged to monitor the HealthyCanadians website for updates to the list and for information on other products that may pose a serious risk to their health.

Manufacturer Name Some Identified Points of sale Date Added
Carful Company Ltd. SI-808 ebay, amazon, www.hisupplier.com, www.prototype-cn.com, www.aliexpress.com December 5, 2013
BNB Medical Co. Ltd Epsil BSL-10 ebay, www.dsint.en.ec21.com, www.honeybay.com, www.hareway.com December 5, 2013

How to report side effects to unlicenced health products:

Complaints involving unlicenced medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, completing the online complaint form at http://hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/frm-0317-eng.php or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

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