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Heath Canada authorizes certain plasma pens


Heath Canada has updated its advisory for plasma pens, noting that select pens have been authorized for use in Canada.


In an update to a product warning from 2019, Health Canada said on Wednesday it has authorized the sale of “certain plasma pens in Canada for use by health-care professionals only.”


A list of the authorized plasma pens can be found by searching Health Canada’s Medical Devices Active Licence Listing.


According to Heath Canada, plasma pens are small handheld medical devices that generate electrical discharges on the surface of the skin, which causes a controlled burn and spreads heat throughout a targeted area in a non-surgical, non-invasive skin treatment.


The pen sessions, also known as fibroblast, are promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and the removal of moles, skin tags, scars and spots.


In 2019, after seizing plasma pens from spas in Calgary, Heath Canada issued a warning that it had not authorized any plasma pens for sale in Canada because they had not been evaluated for safety, effectiveness or quality.


Health Canada first warned about the risks of using unauthorized plasma pens back in November 2018.


According to Heath Canada, side effects of plasma pen skin treatments include pain, swelling, redness, sagging skin, hyperpigmentation, ultraviolet sensitivity, and skin peeling and crusting.


The agency says these devices can have additional risks, such as skin punctures from the needle, excessive skin burns caused by overuse or prolonged use, and burn complications such as scarring and infection.


Health Canada says the likelihood and severity of side effects increases with the duration and frequency of treatment.


The agency says to avoid buying or using unauthorized plasma pens, or receiving services at spas and by estheticians using these devices, and consult Health Canada’s Medical Devices Active Licence Listing to ensure the device is permitted for use.

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