Red Light Therapy Regulations

Light therapy devices such as Red Light are considered 'Medical Devices'; therefore they are regulated by the FDA.  All States will follow FDA regulations and guidelines.

Red Light devices used for cosmetic and wellness services are available to the public.  They are considered similar to "over the counter" medications.  

Laser and Intense Pulsed Light Devices are used by licensed estheticians and medical professionals because they involve invasive treatments.  These types of devices are more regulated.

State Requirements:

Ohio:

• Cosmetology regulations require users of the devices to register as tanning salons.

Currently no other states have regulations that apply to the "over the counter" devices. 

FDA Oversight Issues:

• Claims made for cosmetic use allowed with no further requirements.
• Claims made for medical treatment are not allowed, including but not limited to hair growth, cure acne, heal wounds.
•  You can only claim uses that are specified on the label.
• Replacing UV Lamps with Red Light Lamps in devices originally approved as tanning equipment.  The FDA wants these re-purposed devices submitted to them for clearance as medical devices. They have requested state regulators to limit this practice.
  • Ohio, Iowa and Oregon have seen this as a problem in their tanning businesses, but "hybrid" lamps, with both red and UV light that are compatible with original tanning lamps has resolved this issue.

Beyond regulations you may wish to verify any limits your business insurance may impose.

Regulation in Canada mirrors US regulations