Buyer's guide
"FDA cleared" is not "FDA approved"
Nearly every aesthetic device sold in the US is cleared, not approved. Approval (a PMA) is reserved for high-risk devices like implantable defibrillators — no laser, RF, or body-contouring platform on this site carries one. Vendors blur the two words because "approved" closes deals faster. Here is what each status actually means when you're writing a six-figure check.
One more thing vendors get wrong: FDA registration and device listing are not authorization of any kind, and the FDA does not issue registration certificates — any "FDA registration certificate" a rep shows you was produced by the company or a third party, not by the FDA.
The manufacturer filed a 510(k) and the FDA agreed the device is substantially equivalent to a device already on the market for a specific use.
Ask for the K-number and read the exact indication. A device cleared for "temporary circumference reduction of the abdomen" is not cleared for arms, and marketing an indication the clearance does not cover is the marketer's own regulatory and advertising exposure; ask the vendor for the cleared indications in writing.
The manufacturer has registered its establishment and listed the device with the FDA, but no clearance review of this device was located. Establishment registration and device listing are not FDA clearance or approval and say nothing about a device's safety or effectiveness (21 CFR 807.39 / 807.97).
Registration and listing are paperwork steps, not a performance judgment. Ask what claims the seller is making and get the regulatory basis for each in writing.
FDA's General Wellness guidance is an enforcement-discretion policy for low-risk products making only general wellness claims (e.g. relaxation, general fitness). It is not a clearance, an approval or an exemption, and it does not cover claims about treating a condition or changing body structure or function — fat reduction, cellulite treatment and skin tightening are outside it.
Claims about a disease, condition or a change in body structure or function are device claims, and the General Wellness policy does not cover them. Ask the seller which cleared indication supports each claim in the brochure.
The device has no US clearance for the use being marketed — often a platform sold widely in Europe, Korea, or Brazil that hasn't been through 510(k) here.
Carriers and state boards may treat a device with no located US clearance differently. Confirm coverage and permitted use with your carrier and medical director before you sign anything.
We searched the public 510(k) database and did not locate a clearance record naming this model.
Treat it as unknown, not as cleared. Ask the manufacturer for the K-number in writing and check it yourself.
How to verify a claim in two minutes
- Ask the rep for the K-number of the exact model and applicator you're buying.
- Search that K-number in the FDA's public 510(k) database at accessdata.fda.gov. The decision summary lists the cleared indication verbatim.
- Compare that wording to the brochure. Any body area, condition or outcome not named in the clearance is not covered by that clearance.
- Confirm the clearance belongs to the current model, not a predecessor with a similar name.
FDA status on this site is compiled from the public FDA 510(k) database and may lag recent submissions. It is research, not legal or regulatory advice — always confirm with the manufacturer and your medical director before purchase.