Learn · FDA terms
FDA cleared vs FDA registered vs FDA approved: what the terms mean
FDA approved means the FDA reviewed evidence that a device is safe and effective, the pathway generally used for the highest risk Class III devices. FDA cleared means the FDA found a device substantially equivalent to one already legally marketed, through a 510(k). FDA registered means a company registered its facility and listed its devices, which the FDA says is not approval or clearance.
What does FDA approved mean?
For medical devices, approval comes through premarket approval (PMA). The FDA uses it for Class III devices, the highest risk class, such as mechanical heart valves and implantable infusion pumps. To approve, the FDA must find sufficient valid scientific evidence that the device is safe and effective for its intended use.
Cosmetics are different. Cosmetic products and ingredients do not need FDA premarket approval, except color additives. The companies that make or market them are legally responsible for their safety.
What does FDA cleared mean?
Generally, moderate risk devices (Class II) reach the market through a premarket notification called a 510(k). The maker shows the device is substantially equivalent to a legally marketed device, and the FDA issues an order that it can be marketed. That is clearance. It is a separate pathway from approval, and each clearance covers a specific device and its stated indications for use.
Anyone can look up a cleared device in the FDA's 510(k) database by device name, company name, or 510(k) number.
What does FDA registered mean?
Companies that make or distribute medical devices for the U.S. must register their facilities with the FDA every year and list the devices made there. The FDA says this entry does not denote approval, clearance, or authorization of the facility or its devices, and the FDA does not issue device registration certificates.
Class I is the lowest risk class. General controls, such as registration and listing and rules on misbranding and manufacturing, apply to all devices and are the only controls for Class I. By the FDA's count, about 74 percent of Class I devices are exempt from 510(k), so they can be marketed without a clearance.
How do these terms apply at The Root & Scalp Spa?
| What it is | Where it is used | FDA status |
|---|---|---|
| FoLix™ laser by Lumenis | Step 1 of The Root Method™ | FDA-cleared through 510(k), K242349 |
| Alma TED™ system | Step 3 of The Root Method™ | FDA-registered Class I device. Not 510(k)-cleared. |
| The Hair Lab Proprietary Hair Serum | Step 2 of The Root Method™ | Topical cosmetic. Neither FDA-cleared nor FDA-approved. |
| The Root Method™ as a whole | The three-step program | Not FDA-cleared. Clearance and registration apply to individual devices only. |
| Revian RED at-home LED cap | Optional, not part of The Root Method™ | FDA-cleared through 510(k), K173729 |
| Nutrafol™ supplements | Optional | Statements not evaluated by the FDA |
| Provider-prescribed compounded topicals | Optional | Not FDA-evaluated products |
FoLix™ is cleared for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin types I to IV. Its clearance means the FDA found the device substantially equivalent to a legally marketed device. It is not an FDA endorsement of The Root Method™ or any combined service.
None of the three steps of The Root Method™ is FDA-approved. The Root & Scalp Spa is not a medical practice, and its services are cosmetic.
Common questions about FDA terms
Is FDA cleared the same as FDA approved?
No. FDA approval (PMA) is a review of evidence of safety and effectiveness, generally for the highest risk Class III devices. FDA clearance (510(k)) means the FDA found a device substantially equivalent to a legally marketed device. Both let a device be marketed in the U.S., through different pathways.
Does FDA registered mean the FDA reviewed a device?
No. Registration and listing tell the FDA where devices are made and which devices are made there. The FDA says a registration and listing entry does not denote approval, clearance, or authorization, and it does not issue registration certificates.
Is The Root Method™ FDA approved?
No. No step of The Root Method™ is FDA approved, and the program as a whole is not FDA-cleared. The FoLix™ laser is FDA-cleared through 510(k). The Alma TED™ system is an FDA-registered Class I device. The serum is a cosmetic.
Do cosmetics need FDA approval?
No. Cosmetic products and ingredients do not need FDA premarket approval, except color additives. The companies that make or market cosmetics are legally responsible for their safety.
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