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.
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 that says otherwise is off-label promotion — your liability, not the vendor's.
The device is listed with the FDA but never went through a clearance review, usually because it sits in a low-risk class (many exfoliation, LED, massage, and lymphatic platforms).
"FDA registered" is a paperwork step, not a performance judgment. It is fine for genuinely cosmetic services — just don't let it be sold to you as a clinical claim.
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.
Treating US patients with it can create malpractice-coverage and state-board exposure. Verify with your carrier and medical director before you sign anything.
We haven't finished verifying this device against the public 510(k) database yet.
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 an off-label claim.
- 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.