Regulatory & Quality
Buying a professional laser is buying a regulated medical device. Here is how to confirm a device is properly licensed in Canada, what the common clearances mean, and the quality system behind everything we distribute.
Health Canada licensing (MDL)
In Canada, Class II–IV medical devices — which is where professional aesthetic, dental, and surgical lasers sit — require a Medical Device Licence (MDL) issued by Health Canada. The licence ties a specific device and manufacturer to an authorization to sell in Canada.
You can verify any device yourself. Health Canada publishes the Medical Devices Active Licence Listing (MDALL), a public register of active licences. Search the device, company, or licence number and match the result. Our devices carry documented Health Canada status — for example, the Pro 1 Pico is licensed under MDL 114765. If a supplier cannot give you a licence number you can look up, treat that as the answer.
New to the database? Our step-by-step walkthrough shows you exactly how to search it and read a licence record: How to verify any laser's Health Canada Medical Device Licence in MDALL.
FDA clearance — cleared is not “approved”
Most professional lasers enter the US market through 510(k) clearance: the manufacturer shows the device is substantially equivalent to one already legally marketed. That is different from PMA approval, the stricter pathway for higher-risk devices. Both are legitimate — but they are not interchangeable, and precise language matters. We describe our devices as Health Canada licensed and, where applicable, FDA cleared, never with looser wording.
The four terms — cleared, approved, registered, listed — are not interchangeable, and only two involve FDA reviewing anything. Full breakdown: FDA cleared vs approved vs registered vs listed — what each really means for a laser.
Our quality system: ISO 13485 & MDSAP
We operate an ISO 13485–certified, MDSAP-audited quality management system — the discipline that governs how devices are sourced, documented, and distributed. ISO 13485 is the international quality standard for medical devices; MDSAP is a single audit recognized by multiple regulators, including Health Canada. This is the difference between a certified medical-device distributor and a reseller moving boxes.
Why it matters when you buy
A properly licensed device from a certified distributor protects the clinic in ways a grey-market import does not:
- A verifiable Health Canada licence, so the device is authorized for sale in Canada.
- Cleaner professional-insurance and liability footing.
- Manufacturer warranty, parts, and a real service path — not an orphaned unit.
- Structured clinical training with the equipment.
Unlicensed or grey-market units can carry none of these. The paperwork is part of the product.
Common questions
Is the Pro 1 Pico Health Canada licensed?
Yes. The Pro 1 Pico is licensed by Health Canada under Medical Device Licence (MDL) 114765. You can confirm any active licence yourself in Health Canada’s public MDALL database — you do not have to take our word for it.
How do I verify a medical device’s Health Canada licence?
Search the device name, licence number, or company in Health Canada’s Medical Devices Active Licence Listing (MDALL) — the public register of active Class II–IV device licences. A legitimate device returns an active licence with a matching name and class. No result, or an inactive licence, is a warning sign.
Is “FDA cleared” the same as being “approved”?
No. Most aesthetic and surgical lasers reach the US market through 510(k) clearance — the manufacturer demonstrates the device is substantially equivalent to one already legally marketed. Full pre-market approval (the PMA pathway) is stricter and used mainly for higher-risk devices. If a supplier markets a cleared laser as “approved,” it is worth a second look.
What is ISO 13485 and MDSAP?
ISO 13485 is the international quality-management standard for medical devices. MDSAP (the Medical Device Single Audit Program) is a single regulatory audit recognized by multiple authorities, including Health Canada. Together they indicate a mature, audited quality system behind how devices are sourced, documented, and distributed.
Why buy from a licensed distributor instead of a grey-market import?
An unlicensed grey-market unit may have no valid Health Canada licence, which can expose a clinic to regulatory and liability risk, complicate professional insurance, and leave you without manufacturer warranty, parts, or training. A documented licence and a real service path are part of what you are buying.