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Designed for Safety. Backed by Standards. Trusted by Professionals.

At Medika, protecting your clinic, your clients, and your reputation comes first. Every device we supply is carefully inspected, tested, and quality-checked long before it reaches your hands. From engineering and manufacturing to final delivery, our systems are built to meet—and exceed—the highest benchmarks for safety and performance in the industry.

 

All Medika equipment is fully Health Canada approved and FDA approved, giving you total confidence that your investment meets strict regulatory requirements in both Canada and the United States.

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Health Canada Approved Laser Machines for Clinics, Health canada registered laser machines for sale

COSMETOLOGY ASSOCIATION OF NOVA SCOTIA

MEDIKA#: 31732

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MEDICAL DEVICE ESTABLISHMENT LICENSE

MEDIKA#: 28523

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What Health Canada Approval Means

In Canada, medical and aesthetic laser devices must undergo a strict regulatory review before they can be sold or used in clinics. Health Canada evaluates each device for safety, effectiveness, and quality under the Medical Devices Regulations.

 

Devices are classified by risk level (Class I to Class IV), with most laser and energy-based technologies typically falling into Class II or Class III. Approval confirms that the device has been properly assessed, validated, and authorized for professional use in Canada.

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What FDA Approval Means

In the United States, the Food and Drug Administration (FDA) regulates medical and aesthetic devices. Laser systems are classified based on their intended use and risk profile and must comply with 21 CFR (Code of Federal Regulations) requirements.

 

Most devices require either 510(k) clearance or Premarket Approval (PMA). FDA approval indicates that the equipment meets federal standards for safety, performance, and clinical application.

Safety Goes Beyond the Machine

For us, compliance is only the beginning. At Medika, we believe true safety comes from knowledge, training, and proper protocols. That’s why we provide comprehensive education, certification, and ongoing support—so you and your team can perform treatments with confidence, precision, and responsibility.

Our mission is not only to deliver advanced technology, but also to equip you with the expertise, systems, and tools needed to operate at the highest professional standard.

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Choosing Medika means choosing reliability, quality, and expert-backed confidence.

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