Red Light Therapy Regulations - US and Canada

Red Light Therapy Certification Course Information 

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In the US the FDA regulates light therapy devices because they are considered "medical devices".  Red Light devices for cosmetic and wellness services are available similar to "over the counter" medications; they are available to the public, any one can buy and use them. 

More regulated devices include equipment such as laser and Intense pulsed light devices; these are used only by estheticians or medical professionals because they involve invasive treatments.

No additional state level requirements apply to the "over the counter" devices except that in Ohio cosmetology regulations that require users of the  devices to register as tanning salons.

At issue for FDA oversight are claims made for the use of the devices. When the only claims made are cosmetic  there are no further requirements; claims of disease or medical treatment are not allowed; these would include claims that treatment can produce hair growth, cure acne or heal wounds.  You can claim uses that are on the label.

Another issue in FDA oversight is the replacement of UV lamps with red light lamps in devices originally approved as tanning equipment. The FDA wants these re-purposed devicessubmitted to them for clearance as medical devices. They have issued a memorandum on the practice - https://www.fda.gov/medical-devices/industry-medical-devices/memo-conference-radiation-control-program-directors-red-lamps-skin-rejuvenation-being-installed

They have requested state regulators to limit this practice. A few states, Iowa and Oregon for example, will treat it as an problem in tanning businesses; most states do not treat it as a problem.

Regulation in Canada mirrors US regulations

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


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Last modified: Monday, February 1, 2021, 7:10 PM