Foreo, Inc.

FAQ

Name: Foreo, Inc. FAQ
Brand: Foreo, Inc.

Radiofrequency (RF) skin tightening

Regulatory status

FDA 510(k) cleared

510(k) cleared · Jul 2024 · code PAY

Evidence it works

Mixed/moderate

for the claimed effect — see below

Cleared ≠ proven. An FDA 510(k) clearance means the device may be legally marketed for that use — it is not, on its own, evidence that it works for you. How we grade evidence → Compare with another device →

What it claims

Tightens skin and reduces wrinkles
Stimulates collagen

Manufacturer / marketing claims — not verified by SkinCarisma.

What the evidence says

RF skin tightening has reasonable evidence for in-clinic devices; at-home units deliver less energy, so results are typically subtler and slower. Benefits build over repeated sessions and depend on consistent use.

Specifications

Technology: Radiofrequency (RF) skin tightening
Wavelengths: Not disclosed by manufacturer
Power / irradiance: Not disclosed
Treatment area: —
FDA product code: PAY
510(k) number: K240616
Cleared: 15 Jul 2024

Using this with your skincare

How this device plays with the actives in your routine.

Watch out for

Don't use straight after exfoliating acids or retinoids — a compromised barrier plus heat invites irritation.
Follow manufacturer guidance around recent injectables/fillers.

Get the most from it

Use the recommended glide gel and keep skin hydrated.
Space heat-based sessions from your strongest actives, and always wear sunscreen the next day.

General guidance — patch-test new combinations and follow your device's manual.

Safety & who should be careful

A pacemaker, defibrillator or any implanted electronic device
Pregnancy — limited safety data; check with a clinician first
Epilepsy or a seizure disorder
Metal implants, dental braces or piercings in the treatment area
Active infection, broken skin, or recent injectables in the area

General guidance for this device class — always follow your device's manual and check with a clinician.

Sources

FDA 510(k) K240616 — Foreo, Inc. · fetched 2026-06-13

This page is information, not medical advice. Device data comes from the FDA openFDA database and manufacturer filings; SkinCarisma does not independently test devices. For your situation, consult a dermatologist. See our methodology.