Royal Red Light devices are low / risk, general wellness products designed to affect the body through topical heating and supporting cellular function. Royal Red Light is
registered with the FDA and a certain subset of Royal Red products have obtained 510(k) clearance.
Under the 1976 Amendments to the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration (“FDA”) regulates the bringing of new medical devices to market. 21 U.S.C. § 360c. FDA classifies devices into one of three categories based on the risk they pose to the public. § 360c(f); see also 21 C.F.R. § 860.3 (2018).
Under FDA regulations, marketers cannot sell higher-risk products without premarket approval from FDA, a regulatory pathway that includes a rigorous review of safety and efficacy data. FDA, Device Advice: Comprehensive Regulatory Assistance: Overview of Medical Device Regulation: How to Study and Market Your Device: Premarket Submissions: Premarket Approval (PMA), available at
https://www.fda.gov/medicaldevices/deviceregulationandguidance//howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/Lower-risk devices undergo a less stringent regulatory review, known as the 510(k) regulatory pathway, that does not require clinical data demonstrating efficacy or safety, only a showing that a new device is “substantially equivalent” to an existing device already legally marketed in the United States. FDA, Device Advice: Comprehensive Regulatory Assistance: How to Study and Market Your Device: Premarket Submissions: Premarket Notification 510(k), available at
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k.
These devices are typically referred to as FDA "cleared". The RoyalGROW Helmet and RoyalCLEAR and RoyalGLOW Masks, have 510(k) clearance.
In addition, FDA has exempted some lower-risk devices, such as heating pads and topical heating devices that emit infrared light, (such as all other Royal Red Light devices), from the 510(k) regulatory pathway. Id.; see also 21 C.F.R. § 890.5550 (2018) (exempting infrared lamps from 510(k) premarket notification requirement); 21 C.F.R. § 890.5950 (2018) (exempting powered heating units from 510(k) premarket notification requirement). These 510(k)-exempt devices do not undergo FDA regulatory review before companies bring them to market.
FDA separately requires that manufacturers and distributors of medical devices in the United States register annually and submit a device list, a process known as “establishment registration.” 21 C.F.R. § 807 (2018); FDA, Device Advice: Comprehensive Regulatory Assistance: How to Study and Market Your Device: Device Registration and Listing, available at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listingThe purpose of this registration requirement is to inform FDA where medical devices are made, in the event of a public health emergency to which the agency must respond.
Royal Red Light, LLC's establishment registration can be found here:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=288202To learn more about FDA approval we recommend reading this article on the FDA website:
Is It Really "FDA Approved"?At Royal Red Light, we believe transparency and ethical advertising are non-negotiable. We intentionally avoid superlative or misleading marketing claims- particularly misuse of the term “FDA approved” - because they are both unnecessary and, in our view, highly unethical in the general wellness space. Consumers should be cautious any time they see a company broadly advertising “FDA approval” for low-risk wellness devices; it is often a red flag that regulatory language is being stretched for marketing purposes. We don’t need to do that. Our devices stand on their own merits: best-in-class design, rigorous safety standards, years of independent testing, and over seven years of real-world use by customers who consistently share their results and experiences. We believe trust is earned through honesty, not hype.