Photobiomodulation (PBM) devices are not FDA “approved” in the technical sense, but many are FDA “cleared,” which is a different regulatory pathway. That distinction matters more than most people realize, and it shapes what these devices can legally claim to do, how they’re marketed, and what you should expect from them.
FDA Cleared vs. FDA Approved
The FDA uses different review processes depending on how risky a medical device is, and the words “cleared” and “approved” have specific legal meanings that companies sometimes blur in their marketing.
“FDA approved” refers to devices that go through the Premarket Approval (PMA) process, the most rigorous review the agency conducts. This is reserved for high-risk devices like pacemakers and artificial joints, and it requires extensive clinical trial data proving the device is both safe and effective. Photobiomodulation devices have not gone through this process.
“FDA cleared” means a device went through the 510(k) pathway, where the manufacturer demonstrates that their product is substantially similar to a device already legally on the market. This is a faster, less demanding process. It establishes that the device is reasonably safe for its intended use, but it doesn’t require the same level of clinical proof as full approval. Multiple PBM devices have been cleared through this route.
There’s also a third category the FDA explicitly warns about: “FDA registered.” Any manufacturer can register their facility and list devices with the FDA, but this does not mean those devices have been reviewed, cleared, or approved. The FDA has stated that companies displaying registration certificates alongside product photos to imply agency endorsement are misbranding their devices in violation of federal law. If a PBM product claims to be “FDA registered” rather than “FDA cleared,” that’s a red flag.
How PBM Devices Are Classified
The FDA classifies photobiomodulation devices as Class II medical devices, a category that includes moderate-risk products like powered wheelchairs and pregnancy tests. Class II devices are regulated under several specific product codes, including those covering powered light-based devices used on the skin and musculoskeletal system. As Class II devices, they require a 510(k) premarket notification before they can be legally sold in the United States.
The FDA has issued draft guidance specifically for PBM device submissions, outlining recommendations for the non-clinical testing, clinical studies, and labeling that manufacturers need to include. This guidance covers devices also known as low level light therapy (LLLT) devices, recognizing that the technology goes by multiple names in the market.
What PBM Devices Are Cleared to Treat
FDA-cleared PBM devices have received clearance for a relatively narrow set of uses, primarily temporary relief of minor muscle and joint pain, arthritis pain, muscle spasm, and stiffness. Some devices are also cleared to promote temporary increases in local blood circulation. The specific cleared indications vary by device, so two PBM products on the market may not be cleared for the same things.
Many of the broader claims you’ll see online, such as PBM treating traumatic brain injury, Alzheimer’s disease, depression, or accelerating wound healing, are not FDA-cleared indications. Practitioners may use cleared devices for these purposes off-label, which is legal for healthcare providers, but the devices themselves haven’t been reviewed for those specific uses. This means the FDA has not evaluated evidence that PBM works for those conditions.
How PBM Works at the Cellular Level
The biological basis for photobiomodulation is reasonably well understood. Red and near-infrared light is absorbed by a specific component inside your mitochondria, the energy-producing structures in your cells. When this photoreceptor absorbs light, it triggers a chain of events: your cells ramp up energy production, generate signaling molecules, and shift calcium levels. These changes activate pathways that influence cell growth, movement, and specialization. It’s a real physiological effect, not pseudoscience, but having a plausible mechanism isn’t the same as having proven clinical effectiveness for every condition it’s marketed for.
General Wellness Products vs. Medical Devices
Not every light-emitting product falls under the FDA’s medical device oversight. The FDA has noted that some light-emitting products intended only for general wellness use and presenting low risk to users may fall outside the scope of its PBM device guidance. This creates a gray area in the market. Many consumer LED masks, panels, and handheld devices are sold as “wellness” products rather than medical devices, which means they haven’t gone through 510(k) review at all.
For you as a consumer, this means the regulatory status of PBM products varies enormously depending on what the manufacturer claims the product does. A device marketed to “temporarily relieve minor muscle pain” would need FDA clearance. A device marketed to “support your body’s natural wellness” might not. The technology inside could be nearly identical. You can verify whether a specific device has been cleared by searching the FDA’s Devices@FDA database, which catalogs all cleared and approved medical devices.
Safety Standards for PBM Devices
PBM devices that use laser light must meet the FDA’s laser performance standards, which set requirements for safety features, labeling, and maximum output levels. The FDA recognizes certain international safety standards as comparable to its own requirements. Manufacturers who comply with those international standards generally satisfy FDA safety rules as well.
For LED-based PBM devices (which use non-coherent light rather than lasers), the safety requirements are somewhat different and generally less stringent, since LEDs pose a lower risk of eye or tissue damage at the power levels typically used. Still, both laser and LED devices sold as Class II medical devices must demonstrate they meet applicable safety and electromagnetic compatibility standards as part of their 510(k) submission.
What This Means When Shopping for PBM
If you’re considering a PBM device, look for specific 510(k) clearance numbers rather than vague claims about FDA status. A legitimate manufacturer will list their clearance number and the exact indications the device is cleared for. Be skeptical of products that claim FDA clearance for conditions like cognitive decline, hair regrowth, or skin rejuvenation without providing a verifiable clearance number for that specific claim, as those may fall outside what the FDA has actually reviewed.
The bottom line: photobiomodulation is a real technology with a recognized biological mechanism, and certain PBM devices have been FDA cleared as Class II medical devices for specific, limited uses like temporary pain relief. But “FDA cleared” is not the same as “FDA approved,” and many of the more ambitious health claims made about PBM have not been evaluated through any FDA pathway.