class-4-laser-requirements

Professional diode and picosecond lasers are often classified as Class 4 lasers. This classification entails the highest safety requirements and places clear demands on both the supplier and the clinic.

When investing in Class 4 laser equipment, it is crucial to understand the regulatory responsibilities.

What does class 4 laser mean?

Laser classification indicates risk level based on power and potential exposure.

Class 4 lasers:

• Has high impact
• May cause eye damage from direct or reflected radiation
• Requires controlled safety procedures
• Used in professional medical and aesthetic practice

Most professional diode lasers, including 808 nm systems, fall into this category.
See example of professional diode laser here:
https://velurex.dk/produkter/diode-laser-808nm-1600w

What requirements apply in Denmark?

In Denmark, class 4 lasers must comply with:

• CE marking in accordance with applicable EU legislation
• Technical documentation
• Risk assessment
• Instructions for use in relevant language
• Compliance with occupational health and safety requirements

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

The clinic's responsibility

It is important to understand that CE marking alone does not exempt the clinic from liability.

The clinic must ensure:

• That the equipment is correctly installed
• That personnel are instructed in safe use
• That security measures have been implemented
• That documentation can be presented during inspection

Read more about the clinic's responsibilities here:
https://velurex.dk/compliance/klinikkens-ansvar

Class 4 laser safety precautions

Use of class 4 laser typically involves:

• Use of approved safety glasses
• Access control to treatment rooms
• Warning signs
• Emergency procedures

Safety is an integral part of professional clinic operations.

Documentation and technical transparency

When purchasing a class 4 laser, the following should be reviewed:

• EU Declaration of Conformity
• Technical dossier
• Classification and risk assessment
• Serial number and traceability documentation

Velurex works with transparency in the documentation process for professional clinics.

If you would like to discuss regulatory matters when purchasing laser equipment, you can contact us here:
https://velurex.dk/kontakt

Relationship between technology and classification

Classification as Class 4 depends on several factors:

• Wavelength (e.g. 808 nm)
• Effect
• Pulse duration
• Beam profile

Read the technical review of 808 nm technology here:
https://velurex.dk/viden/808nm-teknologi-forklaret