Health Canada Approvals

Certified Safe. Professionally Approved. Trusted by Experts.

At Radiant Laser, your safety and success are our top priorities. That’s why every single machine in our lineup undergoes rigorous testing and quality assurance checks before it ever reaches your hands. From engineering to delivery, our devices are built to the highest performance and safety standards in the industry.

We are proud to say that all Radiant Laser devices are Health Canada Approved and FDA Approved—giving you the confidence and peace of mind you deserve.

What Does Health Canada Approval Mean?

In Canada, all medical and aesthetic laser devices must be reviewed and approved by Health Canada before they can be legally sold or used. This regulatory process ensures that each device meets strict safety, efficacy, and quality control standards under the Medical Devices Regulations. Devices are classified by risk level (Class I to Class IV), with laser and energy-based systems generally falling into Class II or Class III. Health Canada’s approval means the device has been tested, proven safe, and authorized for use within Canadian clinics.

What is FDA Approval?

In the United States, the Food and Drug Administration (FDA) is the governing body that approves medical and aesthetic devices. Laser equipment is categorized based on intended use and risk, and must meet requirements under 21 CFR (Code of Federal Regulations). Most laser devices are Class II or III, requiring 510(k) clearance or Premarket Approval (PMA). FDA approval ensures the equipment is safe, effective, and compliant with U.S. federal standards.