The page is a summary of the regional and special requirements for laser therapy. This resource is not 100% complete so please check your local regulatory agencies to confirm that there are not further requirements. If you know of a regional requirement, please send us information so we can keep this page up to date.

US Laser Therapy Requirements

In general, there just 2 requirement from the FDA:

  • Class 1 and 2 systems are OTC (over the counter) with no restictions on anyone. Class 3 and 4 lasers can be sold to ANY health care professional and they can be sold for home use with a recommendation from a health care professional. Many manufacturers have a doctor on staff who writes the letters to stay in compliance so often this is often included in the price. This requirement is on the manufacturer and not the buyer. If the manufacturer gets audited and can not produce the documentation, they might be fined by the FDA.
  • No one can advertise for a service using a cold laser that is not related to pain control, inflammation control or increasing blood flow. Some one who is misrepresenting their health care service can be fined or loose their license.

US State Specific Regulations

In addition to the FDA requirement, some states have created laws to support special interest groups and stifle competition and growth in the cold laser market.

Colorado Regulations
Equine Use: Only licensed veterinarians can use a laser on horses as part of a business.


Texas
Equine Use: Only licensed veterinarians can use a laser on horses as part of a business.
Human Use:  In order to use a laser as part of a business in Texas, the laser must be registered and the owner must pay a fee every 2 years. The application for a license must be signed by a licensed practitioner.

Canada Therapy Laser Requirements

Human Use: Any professional using a laser to treat humans in their practice in Canada, must use a laser that is Health Canada approved. The lasers that we sell that are Health Canada approved are:

 

 

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