Clinical Use of Laser – Rules and Requirements

Clinical use of lasers in Denmark is permitted but regulated. Professional clinics must ensure proper documentation, safety measures and compliance with applicable EU regulations.

It is not enough that the equipment is CE marked – it must also be used correctly.

What does clinical use entail?

Clinical uses of laser include:

• Use in professional treatment environments
• Documented CE marking
• Compliance with safety procedures
• Storage of relevant documentation

Read about CE and MDR here:
https://velurex.dk/pages/ce-og-mdr

Class 4 and safety

Many professional lasers are classified as Class 4. This entails special safety requirements.

Read about laser class 4 here:
https://velurex.dk/pages/laser-klasse-4

Read about safety here:
https://velurex.dk/pages/class-4-laser-safety

Documentation requirements

For clinical use, the following documentation should be available:

• EU Declaration of Conformity
• Instructions for use
• Risk assessment
• Service history

Read about documentation when purchasing here:
https://velurex.dk/pages/dokumentation-ved-koeb-af-klinikudstyr

Read about the technical dossier here:
https://velurex.dk/pages/teknisk-dossier

Responsibility and role distribution

Responsibility may be divided between the manufacturer, importer and clinic.

Read about responsibility when using here:
https://velurex.dk/pages/ansvar-ved-brug-af-laser

Read about imports here:
https://velurex.dk/pages/import-af-medicinal-udstyr

Technological understanding

Correct clinical use requires understanding of:

• Wavelength
• Effect
• Pulse duration
• Cooling system

Read about wavelengths here:
https://velurex.dk/pages/755-vs-808-vs-1064-nm

Read about 1200W vs 1600W here:
https://velurex.dk/pages/1200w-vs-1600w-diode-laser

Contact

If you would like to discuss clinical use of lasers and regulatory requirements, you can contact us here:
https://velurex.dk/kontakt