Short answer: For medical devices, the highest-risk ones generally need premarket approval (PMA) from the FDA, and moderate-risk ones are generally cleared through a 510(k). Some new types get marketing authorization through De Novo. A federal rule says a 510(k) doesn’t denote official approval. Any representation that creates an impression of official approval because of it is misleading and constitutes misbranding.
Before you read: This guide explains what the Food and Drug Administration (FDA) publishes about approved, cleared and authorized medical devices, and the federal rule on references to a 510(k). It is general information, not legal advice.
What the FDA approves, and what it doesn’t
With rare exceptions, new drugs and biological products for people need FDA approval before they are marketed or sold. The highest-risk medical devices generally need FDA approval too.
The FDA says it doesn’t approve health care providers, including physician offices or laboratories.
Cosmetic products and their labeling don’t require FDA approval. Compounded drugs are not FDA approved. By statute, compounders don’t need to prove to the FDA that their products meet the same standards drug manufacturers need to meet.
Our IV therapy marketing guide covers drips made by compounding, and our weight loss ads guide covers compounded drugs in clinic ads.
Approved, cleared or authorized: the device pathways
The FDA classifies medical devices by risk. The highest-risk devices (Class III) generally need FDA approval of a premarket approval application, known as a PMA, before marketing.
A PMA is the FDA’s review of the safety and effectiveness of a Class III device. Approval rests on the FDA finding sufficient valid scientific evidence that the device is safe and effective for its intended use.
Moderate-risk devices (Class II) are generally marketed after a “510(k) clearance.” The maker shows the device is substantially equivalent to a legally marketed device, known as the predicate. The predicate is a device that doesn’t require premarket approval.
Before marketing the device, the maker needs an order, in the form of a letter, in which the FDA finds it substantially equivalent. That order “clears” the device for commercial distribution.
De Novo is a pathway for low- to moderate-risk devices of a new type with no legally marketed predicate. The FDA grants or declines each request. If it grants one, the device is classified as Class I or Class II and gets marketing authorization.
Low-risk devices (Class I) are subject to general controls only, and most are exempt from premarket notification.
What the federal rule says about cleared devices
A federal rule, 21 CFR 807.97, says a 510(k) and the FDA’s finding of substantial equivalence don’t in any way denote official approval of the device.
It adds that any representation that creates an impression of official approval, because the device complied with the 510(k) rules, is misleading and constitutes misbranding.
In our view, use the word the FDA gives each device: approved, cleared or authorized, and “FDA cleared” for a 510(k) device.
The FDA also says registration and listing don’t denote approval, clearance or authorization of a facility or its devices. It doesn’t issue device registration certificates.
It says firms that misleadingly display certificates alongside information about and photos of a device for sale, to imply FDA review or approval, misbrand the device. And its logo is for official government use only.
In our view, keep the FDA logo and any “FDA registered” or “FDA certified” badge out of a clinic ad.
Where aesthetic treatments fit
The FDA describes dermal fillers as medical device implants it approved for specific uses in the face and the backs of the hands. It approved them for adults over 21.
It also says it reviewed and approved different filler products for specific areas of the face and hands. It hasn’t cleared any dermal filler for body contouring injections, and those uses are not approved.
For non-invasive body contouring devices, the FDA reviews safety and effectiveness for the intended uses and body sites before a device is legally authorized. It says none is cleared or approved for treating the breasts.
Our body contouring marketing guide covers what those ads can promise on Meta and Google, and our laser hair removal marketing guide covers claims, prices and audiences.
In our view, the claim belongs to the device and the use the FDA reviewed, never to your clinic, your staff or your results.
How to check a device before you write the ad
The FDA points to its Devices@FDA database, a catalog of approved and cleared medical device information. You can search it by device name or company name.
For De Novo devices, it points to its De Novo database, for low- to moderate-risk devices of a new type that may be authorized for marketing.
In our view, if you can’t find a device in those databases, leave the FDA out of the ad until the manufacturer shows you the device in one of them.
Our med spa marketing page notes that injectables and lasers bring their own rules, set by Google, the FDA, Florida and the FTC. It lists our work for med spas, such as a page for each treatment and Google Search campaigns in an account in your name.
Before an ad mentions the FDA
- You know whether the FDA approved, cleared or authorized each device you name, and for which use.
- “FDA approved” appears only next to a product the FDA approved, such as a device with a PMA.
- A 510(k) device is called “FDA cleared,” with no wording that suggests official approval.
- Nothing says the FDA approved your clinic, your staff or your results.
- The ad carries neither the FDA logo nor an “FDA registered” or “FDA certified” badge.
- Each claim stays within the use and the body area the FDA reviewed.
RememberClass III devices generally need FDA approval through a PMA, and Class II devices are generally cleared through a 510(k). A federal rule says a 510(k) doesn’t denote official approval of the device.
Questions about FDA approved and FDA cleared
What is the difference between FDA approved and FDA cleared?
For devices, approval follows a premarket approval (PMA) review of a Class III device, based on sufficient valid scientific evidence of safety and effectiveness. Clearance follows a 510(k), where the maker shows the device is substantially equivalent to a legally marketed predicate that doesn’t require premarket approval.
Can a clinic say it is FDA approved?
The FDA says it doesn’t approve health care providers, including physician offices or laboratories. It approves products, such as new drugs, biological products and the highest-risk medical devices, after its review.
Is “FDA registered” the same as FDA cleared?
No. The FDA says registration and listing don’t denote approval, clearance or authorization of a facility or its devices. It doesn’t issue device registration certificates, and its logo is for official government use only.
What does FDA authorized mean for a device?
A low- to moderate-risk device of a new type, with no legally marketed predicate, can go through the De Novo pathway. If the FDA grants the request, the device is classified as Class I or Class II and gets marketing authorization. The FDA keeps a De Novo database you can search.
Are dermal fillers FDA approved?
The FDA says dermal fillers are medical device implants it approved for specific uses in the face and hands, for adults over 21. It says it hasn’t cleared any dermal filler for injection in body contouring procedures, and that those uses are not approved.
Sources
Read on November 10, 2026. From the FDA: Is It Really ‘FDA Approved’? Premarket Approval (PMA), Premarket Notification 510(k) and De Novo Classification Request. Also from the FDA: Are There “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved? Dermal Fillers (Soft Tissue Fillers) and Non-Invasive Body Contouring Technologies. From the eCFR, up to date as of November 6, 2026: § 807.97 Misbranding by reference to premarket notification.