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The regulatory environment for Light Therapy is relatively light as long as you are offering cosmetic services and not offering esthetician or medical treatments that can be described generally as invasive treatment or treatments that remove tissue.

The Food and Drug Administration (FDA) regulates light therapy devices as "medical devices". These medical devices are categorized in 4 classes. Class 1 and 2 devices are treated like over the counter devices and anyone can buy and use them. Class 3 and 4 devices can only be purchased and used by licensed professionals. These more regulated devices include equipment such as laser and Intense pulsed light devices.

The light therapy equipment we have been covering are considered Class 1 devices. There are no state level additional requirements targeted at these Class 1 devices except for Ohio cosmetology regulations that require users of Class 1 light therapy devices to register as tanning salons.

Another issue subject to FDA oversight is the claims made for the use of the devices. As long as only cosmetic claims are made there are no further requirements but claims of disease or medical treatment are not allowed. For example, you can not claim that your equipment with produce hair growth, cure acne or heal wounds. A doctor can say that, but you may not.

A special case in FDA oversight is the replacement of UV lamps with red light lamps in devices originally approved as tanning equipment. The FDA's position is that these re-purposed devices should be submitted to them for clearance as medical devices. They have issued a memorandum on the practice published here - 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 issue in tanning or cosmetology businesses; most states, North Carolina for example, are not treating it as a problem.

Your business insurance may also enforce limitations on the treatments you can offer and the claims you can make for treatments.

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