FDA Regulatory Status
This page provides U.S. FDA regulatory information for Red Light Wellness whole-body red light therapy beds.
Device classification and listing
The Max Miracle 9600, Big Miracle 7200, and Miracle 5040 are listed with the U.S. FDA as Class II devices under product code ILY (21 CFR 890.5500, “infrared lamp,” a physical-medicine classification).
Manufacturing establishment
These beds are manufactured in an FDA-registered medical-device establishment in St. Louis, Missouri (FDA Establishment Registration No. 3006190476, registered to Apollo Megasun LLC).
What this means
FDA establishment registration and device listing are administrative facts about the manufacturer and the device type. They are not a statement about the clinical outcome any individual will experience.
Personal Wellness Shop devices
Personal-use devices sold in the Personal Wellness Shop do not carry the regulatory status stated above for the listed whole-body beds.