Is Laser Hair Removal FDA Approved?

The Food and Drug Administration (FDA) is a government agency established in 1906 with the passage of the Federal Food and Drugs Act.1 The agency is separated into divisions that oversee a majority of the organization's obligations involving food, drugs, cosmetics, animal food, dietary supplements, medical devices, biological goods, and blood products.

The FDA is known for its work in regulating the development of new drugs. The FDA has developed rules regarding the clinical trials that must be done on all new medications. Pharmaceutical companies must test drugs through four phases of clinical trials before they can be marketed to individuals.

The FDA is relevant for investors specifically in regards to biotech and pharmaceutical companies. FDA approval can be crucial to companies that are heavily involved in developing new drugs. Without the agency’s approval, regulated products under the FDA's purview cannot be released for sale in the United States.

The FDA is responsible for inspecting and reviewing production facilities that make items that are regulated by the agency. This includes but is not limited to vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, animal feed processors, and compounding pharmacies.

How does laser hair removal work?

Laser hair removal is a long-term hair reduction method that uses selective photothermolysis. The laser gun will match a specific wavelength to a determined pulse duration meant to target an object at the surface of the skin. Such technique will not damage surrounding skin tissues.

Despite the increased use of lasers, to date, few guidelines exist in terms of how to approach laser hair removal. Specifically, one must understand the mechanism of hair growth and how lasers work to target the hair follicle.

Your laser technician will map out and mark the area you want to be treated and provide you with goggles while also wearing their own.The laser gun will produce a beam of light that will target the pigments in the hair. Once the energy is in the hair, it will travel all the way through to the follicle, under the dermis.There, the energy will turn into thermal energy. The heat is what will damage the hair follicle, thus preventing any further growth.

What the thermal energy actually does is cauterizing the blood vessels that feed the hair follicles on the targeted area. Once the follicle no longer gets its fuel, it dies. Only a permanently damaged hair follicle will allow for permanent hair removal. Indeed, if the follicle manages to regenerate, it will produce new hair.

No contraindications for laser hair removal so far.

FDA-approved laser hair removal

1995 the first FDA-approved laser hair removal device was introduced, the SoftLight by ThermoLase. However, FDA approval does not mean that a device is effective; it just means that according to the FDA’s inspectors, it is not acutely dangerous and makes no medicinal claims that have not been substantiated by research.

The SoftLight used a carbon-based lotion which was rubbed into the skin immediately following hair removal by waxing. Theoretically, the lotion would penetrate into the open hair follicle, and then the laser would be applied to heat the accumulated carbon and destroy the follicle. However, this device proved less effective than light devices that targeted the hair follicle pigments naturally present in the skin.

The company which produced SoftLight initially made an excellent profit by offering what they claimed was permanent hair removal through a chain of proprietary clinics called Spa Thira. However, by 1997, a medical study which followed treated patients found full hair regrowth, and in 1998 and 1999 successful lawsuits against the company forced it to cease manufacturing the devices.

The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change.

Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair.