Is REVIAN FDA-Cleared or FDA-Approved? What is the difference?
REVIAN is a class II, FDA-Cleared medical device (#K173729). Because we are considered a red light therapy device similar to others in light output and within the large range of “red” light, for clearance we were required to file a 510K submission based on other predicate devices. This submission included all safety testing of our device according to IEC 60601 and other safety testing needed for medical devices in this category.
FDA Definitions
Cleared medical devices: These medical devices are devices that the FDA has determined to be substantially equivalent to another legally marketed device. A pre-market notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.
Approved medical devices: Approved medical devices are those devices for which the FDA has approved a pre-market approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the devices with the highest risk) and involves a more rigorous review than the 510(k) review process.