The FDA broadly defines low-level light therapy (LLLT) devices, also known as photobiomodulation (PBM) devices, as the application of light at an irradiance that does not induce heating with the goal of altering biological activity.

See, e.g., Warning Letter CMS #612354

The LLLT devices currently recognized are regulated under Sections 21 C.F.R. 878.4810, 878.4860, 878.5400, and 890.5500. The product codes related to those regulations are listed in the table below.

LLLT devices that comply with the registration, pre-market clearance, and import requirements are Lawful LLLT Devices. More Information Here:

The discussion below can be extended to malpractice litigation by patients treated with an Unlawful Medical Device. Click Here

If a provider bills State and Federal healthcare programs for Unlawful Medical Devices, there is a risk of prosecution for False Claim Act violations. Providers may be entangled in their suppliers' FCA investigations even if they do not bill healthcare programs. This would require hiring appropriate legal defense counsel and time 7 away from their practice to provide testimony and/or evidence. Import Alert

DOJ Press Release

In preparing this letter, I reviewed the following online listings:  

• CuraYou  

• LZR UltraBright  

• Inlight  

• NeuroCare Pro  

CuraYou offers the “Neuropath Light Therapy System” on its website. This device is 9 described as using red LED light therapy and thus is an LLLT device. The website  states the device will “relieve neuropathic pain” and “heals foot neuropathy,” among  numerous other claims. The use of red LED light for neuropathic pain will require  FDA clearance, which the company claims to have. However, searching “CuraYou”  and “Leva Health” produced no results in the FDA’s medical device registration 10 database, which captures all registered companies regardless of device 11 classification. It is possible the registration has lapsed, the device is cleared under the  name of a contract manufacturer, or some other circumstances explain the failure to  appear in the FDA’s database. Until otherwise established and verified, it would be  prudent to treat this device as an unapproved LLLT device that poses a risk to  purchase or use.  In contrast, NeuroCare Pro claims FDA registration but not 510(k) clearance. A  search for the company produced an entry in the FDA’s medical device registration .

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