When shopping for a beauty device, you often see “FDA cleared” or “CE marked” on product pages. But what do these labels really mean, and how do they differ?

FDA (USA): Most home-use devices obtain 510(k) clearance, meaning they are “substantially equivalent” to an already legally marketed device. Note: FDA cleared ≠ FDA approved (the latter is for high-risk medical devices). Always check the clearance number on the FDA database.

CE (EU): Under the MDR, medium-to-high risk devices require Notified Body involvement. CE marking indicates compliance with EU safety, health, and environmental standards, but not all CE devices have the same level of clinical evidence.

Other regions: UKCA (UK), TGA (Australia), etc., each have their own requirements.

Three tips for consumers:

1. Don’t be fooled by “FDA registered” – registration is not clearance or approval.
2. Ask for the specific certificate number and verify its validity.
3. RF devices face stricter rules worldwide; choose those with at least one major certification.

A trustworthy beauty device proudly displays its credentials. Your skin deserves that transparency.