Counterfeit Laser Devices in Canadian Clinics

What Health Canada Found

Authentic Soprano devices are manufactured by Alma Lasers Ltd., based in Israel. The counterfeit units found in Canadian clinics are labelled as manufactured by Beijing Perfectlaser Technology Co., Ltd.¹

According to the advisory, the company supplied a falsified medical device licence and falsely presented the products as authorized medical devices. The legitimate manufacturer confirmed the devices are counterfeit. Health Canada notes that counterfeit health products are not the same as authentic ones and may pose serious health risk due to their unknown safety and effectiveness — and that selling counterfeit health products is illegal in Canada.¹

Major Canadian outlets, including CTV News/CP24 and the Toronto Sun, covered the advisory on September 21, 2026, underscoring that these devices reached real clinics and that patients who experience concerning symptoms after laser treatment should seek medical assessment.^2,3

A quick clarification: the Toronto Sun's headline uses the word "recalled" as journalistic shorthand. Health Canada's own language is "stop using and dispose," which isn't the same as a formal product recall in the pharmaceutical sense. Everything else in this article reflects Health Canada's actual wording.

Why Counterfeit Devices Are a Real Concern

Laser devices used for hair removal and other aesthetic treatments are regulated as medical devices in Canada. Legitimate devices go through a licensing process so regulators have evidence of safety and performance for their intended use. When a device is counterfeit or unlicensed, that oversight is missing entirely.

Even properly chosen and operated lasers carry known risks, including temporary pain, redness, swelling, blistering, burns, pigment changes, and, in some cases, scarring. Health Canada notes that the wrong device or improper technique increases the chance of permanent scarring and other complications.⁴ Counterfeit devices add another layer of uncertainty on top of that: output power, cooling, wavelength accuracy, and built-in safety features may not match what a properly licensed device is designed to deliver.

The Scale of the Problem, in Numbers

A 2020 national survey of ASDS/ASLMS members found that most respondents viewed counterfeits as less reliable, less safe, and less effective than authentic devices, and the majority considered them very or extremely endangering to patient safety.⁵ Members of the same research group had earlier raised concerns about counterfeit esthetic devices and patient safety in a short commentary.⁶

Earlier clinical alerts in the laser literature have documented burns and other injuries linked to counterfeit aesthetic systems, noting that these devices offer no assurance of safety, reliability, or reproducible tissue effects compared with properly cleared platforms.⁷

A 2021 study in Cutis searched Alibaba.com and DHgate.com for six categories of FDA-cleared dermatologic devices — including picosecond and fractionated lasers, radiofrequency skin tightening, and cryolipolysis systems — and found 47,055 counterfeit product listings across the two sites. Pricing was wildly inconsistent even for the "same" device: one fractionated laser system averaged US $8,105.80 on Alibaba versus US $3,409.14 on DHgate, with individual listings ranging from $2,300 to $32,000. And 10.7% of listings falsely claimed FDA clearance. Nearly all of the listings sampled (100 of 103) originated from China.⁸

This is also a recognized problem at the regulatory level in the United States, not just in Canada. In January 2021, Congress passed the Safeguarding Therapeutics Act, which amended the Federal Food, Drug, and Cosmetic Act to give the FDA explicit authority to refuse admission of, and destroy, counterfeit medical devices — authority it already had for counterfeit drugs but had lacked for devices.^9,10 The Act also created a formal legal definition of a "counterfeit device": one that, without authorization, bears the trademark, trade name, or other identifying mark of a legitimate manufacturer, and thereby falsely purports to be that manufacturer's product.^9,10

In practical terms, that's the exact pattern Health Canada describes in the Soprano advisory — a device using another company's branding without authorization to look like an authentic, authorized product. It isn't just a paper problem, either. U.S. federal prosecutors have brought real criminal cases involving counterfeit and misbranded aesthetic devices. In one 2023 case, a California man pleaded guilty to running a nearly $6 million scheme selling remanufactured, falsely "new"-labelled skin-tightening transducers alongside counterfeit components for fat-reduction laser machines; he was later sentenced to 30 months in federal prison and ordered to pay roughly $5.9 million in restitution.¹¹ Two national regulators, on two sides of the border, are independently treating counterfeit aesthetic devices as a serious enough problem to build specific legal tools — and in the U.S. case, bring criminal prosecutions — around it.

What Clinics Are Being Told to Do

Health Canada's guidance for clinics is straightforward:

• Verify the device by comparing the permanent label (manufacturer name, device name, and model or catalogue identifier) against the corresponding entry in Health Canada's Medical Devices Active Licence Listing (MDALL).
• If the device is counterfeit, stop using it and dispose of it safely.
• If there is any doubt, contact the legitimate manufacturer for confirmation.^1,12

Health Canada also provided a direct contact line for clinics or clients with questions: 1-866-225-0709 or [email protected].³

What Clients Can Reasonably Ask

You don't need to become a regulatory expert, but a few practical questions are fair to ask before any laser or energy-based treatment:

• What device is being used for the treatment?
• Is the device licensed by Health Canada for this use?
• Can the clinic confirm the manufacturer, and that the unit appears in the Medical Devices Active Licence Listing?

A reputable clinic should be able to answer these without defensiveness. Very low prices, vague answers about the equipment, or pressure to proceed without clear information are reasonable reasons to pause.

It's also worth knowing that in Canada, Health Canada licenses the device itself, but there is no federal or provincial requirement governing who is allowed to operate it. A 2010 CMAJ editorial and accompanying feature noted that "anyone, trained or not, can legally operate a laser machine for hair removal in Canada," and that the onus effectively falls on the client to judge both the equipment and the operator's competence.^13,14 That reporting is now 16 years old, and clinic practices and training vary by province, but the underlying regulatory gap it describes — device licensing without operator licensing — remains accurate today. It makes it reasonable to also ask about the operator's training and experience, not just the machine's paperwork; a genuine device in untrained hands still carries real risk.

If you've already had laser treatment and experienced concerning symptoms — significant pain, unusual redness, swelling, blistering, or pigment changes — Health Canada advises consulting a licensed healthcare professional and, if appropriate, reporting the issue.^1,4

Broader Context

This advisory is specific to counterfeit Soprano-branded diode laser systems. It is not a blanket statement about all laser hair removal or all aesthetic devices. It does, however, underline a recurring issue in the aesthetics industry: not every machine that looks legitimate is properly authorized, and the gap between a licensed device and a counterfeit one can matter for safety.

It sits alongside a second, related gap in Canada — that the operator's training isn't regulated the way the device is — which means "is the equipment real" and "is the person using it qualified" are both fair questions to ask. And as the U.S. side shows, this isn't a uniquely Canadian issue. It's one that two major national regulators have both had to build specific legal and enforcement responses around.

For anyone considering waxing, thermolysis, or microneedling-based treatments instead of laser, the same underlying principle applies: ask what's being used on you, and ask who's using it. At Hideaway Spa, I'm happy to walk clients through exactly what thermolysis or waxing involves and how it's performed.

Key Takeaways

1. This Was a Real, Specific Advisory: Health Canada confirmed counterfeit "Soprano" laser devices, falsely labelled and falsely licensed, reached Canadian clinics.
2. Counterfeits Are a Documented Industry Problem: Survey data shows over a third of dermatologic providers have encountered counterfeit devices, and tens of thousands of counterfeit listings exist online for common aesthetic device categories.
3. Device Licensing Does NOT Guarantee Operator Training: In Canada, the machine may be regulated, but who's allowed to operate it largely isn't. Both matter.
4. It's Reasonable to Ask Questions: A trustworthy clinic should be able to confirm their equipment's manufacturer and licensing without hesitation.
5. This Isn't Just a Canadian Story: U.S. regulators and prosecutors have pursued their own legal tools and criminal cases against counterfeit aesthetic device sellers, showing this is a recognized cross-border problem.

Final Thoughts

Advisories like this one can sound alarming, but the practical takeaway is fairly simple: the skill of the provider matters, and so does the legitimacy of the equipment they use. Asking a few direct questions before treatment — about the device, its licensing, and the operator's training — isn't rude or excessive. It's exactly what Health Canada itself is now asking clients and clinics to do.

If you have questions about the hair removal or skin treatments I offer at Hideaway Spa, including how thermolysis and waxing compare to laser-based options, I'm always happy to talk it through before you book.

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