Red Light Therapy’s Regulatory Implications

Red and near-infrared light therapy, referred to as photobiomodulation or PBM by the medical community, has recently moved from clinical environments and into the consumer health industry. Devices are now widely marketed for a wide-variety of uses pertaining to skin, hair, and general wellness.

Scientific research in PBM continues to develop and NIH-funded studies have examined its potential effects on mitochondrial stimulation and influencing modulation. Simultaneously, the commercial device market has grown immensely as it is further fueled by growing investor interest and consumer demand.

Unfortunately, the regulatory structure that governs these products is rarely discussed. In the United States, many red light therapy products reach the markets through different regulatory pathways depending on their intended use and marketing claims.

Several products have received FDA clearance through the 510(k) process for specific indications. For example:

The 510(k) pathway requires that manufacturers show that their devices are substantially equivalent to an already legally marketed product and must define its intended use, with marketing consistent with those approved uses.

Some are marketed under the FDA’s General Wellness Policy, which enables certain low-risk products that promote general health and avoid disease claims to enter the market without premarket review. This means that two devices emitting similar wavelengths of light can fall under different regulatory classifications dependent on the claims they make and how they market their product. For investors, founders, and consumers this carries practical implications and breeds confusion in the market.

Many consumers understand the terms “FDA-cleared” and “FDA-registered” to have the same meaning, when they are not. FDA clearance means a device has undergone review by the agency for a specific intended use. FDA registration refers to manufacturers registering its facility and listing its device with the agency, yet it doesn’t necessarily mean the product has been cleared. General wellness products may not require premarket review at all if they meet low-risk criteria and avoid disease-treatment claims.

These classifications affect where money is placed and how a product is marketed. By ensuring that an effective classification is put in place, credibility will strengthen and consumers will better understand a device’s intended use. A few years ago, LumiThera received FDA De Novo authorization for its Valeda Light Delivery System to treat dry age-related macular degeneration. That decision created a new regulatory category for this type of device, emphasizing that photobiomodulation is entering more intricate areas of medicine.

These distinctions for investors matter, as companies that invest in structured regulatory pathways may face higher upfront costs, but they will benefit from clearer consumer understanding and product defensibility.

For consumers and clinicians, however, the difference between “FDA-cleared,” “FDA-registered,” and general wellness products is not always obvious. Clear communication about intended use and supporting evidence is essential for maintaining trust.

Red and near-infrared light therapy does not present an inherent regulatory issue. However, it reflects how emerging health technologies can evolve across multiple frameworks at once and how separate classifications can lead to consumer confusion. As research advances regulatory clarity can function as strategic infrastructure helping eliminate consumer confusion and shape commercialization.

Photo: Getty Images, Sarah Silbiger

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